Patient and public involvement in abortion research: reflections from the Shaping Abortion for Change (SACHA) Study.

Patient and public involvement (PPI) is limited within abortion-related research. Possible reasons for this include concerns about engaging with a stigmatised patient group who value confidentiality and may be reluctant to re-engage with services. Structural barriers, including limited funding for abortion-related research, also prevent researchers from creating meaningful PPI opportunities. Here, we describe lessons learnt on undertaking PPI as part of the Shaping Abortion for Change (SACHA) Study, which sought to create an evidence base to guide new directions in abortion care in Britain.Two approaches to PPI were used: involving patients and the public in the oversight of the research and its dissemination as lay advisors, and group meetings to obtain patients' views on interpretation of findings and recommendations. All participants observed the SACHA findings aligned with their own experiences of having an abortion in Britain. These priorities aligned closely with those identified in a separate expert stakeholder consultation undertaken as part of the SACHA Study. One additional priority which had not been identified during the research was identified by the PPI participants.We found abortion patients to be highly motivated to engage in the group meetings, and participation in them actively contributed to the destigmatisation of abortion by giving them a space to share their experiences. This may alleviate any ethical concerns about conducting research and PPI on abortion, including the assumption that revisiting an abortion experience will cause distress. We hope that our reflections are useful to others considering PPI in abortion-related research and service improvement.

Development and Validation of a Brief Measure of Sexual Wellbeing for Population Surveys: The Natsal Sexual Wellbeing Measure (Natsal-SW).

Sexual wellbeing is an important aspect of population health. Addressing and monitoring it as a distinct issue requires valid measures. Our previous conceptual work identified seven domains of sexual wellbeing: security; respect; self-esteem; resilience; forgiveness; self-determination; and comfort. Here, we describe the development and validation of a measure of sexual wellbeing reflecting these domains. Based on the analysis of 40 semi-structured interviews, we operationalized domains into items, and refined them via cognitive interviews, workshops, and expert review. We tested the items via two web-based surveys (n = 590; n = 814). Using data from the first survey, we carried out exploratory factor analysis to assess and eliminate poor performing items. Using data from the second survey, we carried out confirmatory factor analysis to examine model fit and associations between the item reduced measure and external variables hypothesized to correlate with sexual wellbeing (external validity). A sub-sample (n = 113) repeated the second survey after 2 weeks to evaluate test-retest reliability. Confirmatory factor analysis indicated that a "general specific model" had best fit (RMSEA: 0.064; CFI: 0.975, TLI: 0.962), and functioned equivalently across age group, gender, sexual orientation, and relationship status. The final Natsal-SW measure comprised 13 items (from an initial set of 25). It was associated with external variables in the directions hypothesized (all p < .001), including mental wellbeing (0.454), self-esteem (0.564), body image (0.232), depression (-0.384), anxiety (-0.340), sexual satisfaction (0.680) and sexual distress (-0.615), and demonstrated good test-retest reliability (ICC = 0.78). The measure enables sexual wellbeing to be quantified and understood within and across populations.

Improving experience of medical abortion at home in a changing therapeutic, technological and regulatory landscape: a realist review.

OBJECTIVE: To inform UK service development to support medical abortion at home, appropriate for person and context. DESIGN: Realist review SETTING/PARTICIPANTS: Peer-reviewed literature from 1 January 2000 to 9 December 2021, describing interventions or models of home abortion care. Participants included people seeking or having had an abortion. INTERVENTIONS: Interventions and new models of abortion care relevant to the UK. OUTCOME MEASURES: Causal explanations, in the form of context-mechanism-outcome configurations, to test and develop our realist programme theory. RESULTS: We identified 12 401 abstracts, selecting 944 for full text assessment. Our final review included 50 papers. Medical abortion at home is safe, effective and acceptable to most, but clinical pathways and user experience are variable and a minority would not choose this method again. Having a choice of abortion location remains essential, as some people are unable to have a medical abortion at home. Choice of place of abortion (home or clinical setting) was influenced by service factors (appointment number, timing and wait-times), personal responsibilities (caring/work commitments), geography (travel time/distance), relationships (need for secrecy) and desire for awareness/involvement in the process. We found experiences could be improved by offering: an option for self-referral through a telemedicine consultation, realistic information on a range of experiences, opportunities to personalise the process, improved pain relief, and choice of when and how to discuss contraception. CONCLUSIONS: Acknowledging the work done by patients when moving medical abortion care from clinic to home is important. Patients may benefit from support to: prepare a space, manage privacy and work/caring obligations, decide when/how to take medications, understand what is normal, assess experience and decide when and how to ask for help. The transition of this complex intervention when delivered outside healthcare environments could be supported by strategies that reduce surprise or anxiety, enabling preparation and a sense of control.

Effectiveness of a behavioural intervention delivered by text messages (safetxt) on sexually transmitted reinfections in people aged 16-24 years: randomised controlled trial.

OBJECTIVE: To quantify the effects of a series of text messages (safetxt) delivered in the community on incidence of chlamydia and gonorrhoea reinfection at one year in people aged 16-24 years. DESIGN: Parallel group randomised controlled trial. SETTING: 92 sexual health clinics in the United Kingdom. PARTICIPANTS: People aged 16-24 years with a diagnosis of, or treatment for, chlamydia, gonorrhoea, or non-specific urethritis in the past two weeks who owned a mobile phone. INTERVENTIONS: 3123 participants assigned to the safetxt intervention received a series of text messages to improve sex behaviours: four texts daily for days 1-3, one or two daily for days 4-28, two or three weekly for month 2, and 2-5 monthly for months 3-12. 3125 control participants received a monthly text message for one year asking for any change to postal or email address. It was hypothesised that safetxt would reduce the risk of chlamydia and gonorrhoea reinfection at one year by improving three key safer sex behaviours: partner notification at one month, condom use, and sexually transmitted infection testing before unprotected sex with a new partner. Care providers and outcome assessors were blind to allocation. MAIN OUTCOME MEASURES: The primary outcome was the cumulative incidence of chlamydia or gonorrhoea reinfection at one year, assessed by nucleic acid amplification tests. Safety outcomes were self-reported road traffic incidents and partner violence. All analyses were by intention to treat. RESULTS: 6248 of 20 476 people assessed for eligibility between 1 April 2016 and 23 November 2018 were randomised. Primary outcome data were available for 4675/6248 (74.8%). At one year, the cumulative incidence of chlamydia or gonorrhoea reinfection was 22.2% (693/3123) in the safetxt arm versus 20.3% (633/3125) in the control arm (odds ratio 1.13, 95% confidence interval 0.98 to 1.31). The number needed to harm was 64 (95% confidence interval number needed to benefit 334 to ∞ to number needed to harm 24) The risk of road traffic incidents and partner violence was similar between the groups. CONCLUSIONS: The safetxt intervention did not reduce chlamydia and gonorrhoea reinfections at one year in people aged 16-24 years. More reinfections occurred in the safetxt group. The results highlight the need for rigorous evaluation of health communication interventions. TRIAL REGISTRATION: ISRCTN registry ISRCTN64390461.

Achieving proportional representation in a reproductive health survey through social media: process and recommendations.

BACKGROUND: The narrative surrounding women's reproductive health has shifted from a medical model to an emphasis on reproductive well-being over different life-stages. We developed and piloted a tracker survey for monitoring women's reproductive health and well-being in England, recruiting respondents online. This paper reports on the success of the online recruitment strategies in achieving a sample proportionally representative of the England general population. METHODS: Recruitment was through Facebook and Instagram advertisements and dissemination through Twitter and a blog. At the end week one, the sample was reviewed and compared to the 2011 Census England population. From week two, recruitment targeted under-represented groups. Key data were compared with prevalence estimates from the Third National Survey of Sexual Attitudes and Lifestyles (Natsal-3). RESULTS: Between 1 July-17 August 2021, 13,962 people initiated the online survey, with 11,578 completing it. Numbers were low initially, but peaked at 1700 survey initiations per day after increasing the daily advertisement budget on day seven. At the end of week one, minority ethnic groups and people without a degree or equivalent were under-represented. From week two, we altered the advertisement settings to show to people whose profile indicated they were a 'high school leaver' had 'up to some high school', worked in industries that do not typically require a degree or lived in local authorities with a high proportion of ethnic minority residents. This had a modest effect, with the final sample short of proportional representation in terms of ethnicity and education but close in terms of region and age. Compared to Natsal-3, we found consistency in the proportion of respondents reporting an abortion and a live birth in the last year, however, the proportion of our sample reporting ever having experienced infertility was significantly higher than in Natsal-3, as was the proportion of 'planned' pregnancies in the last year. CONCLUSIONS: It is possible to recruit large numbers of respondents online, relatively quickly, to complete a reproductive health survey. This will be valuable to track reproductive health and well-being at a national level over time. More work is needed to understand reasons for non-response among under-represented groups.

Should COVID-specific arrangements for abortion continue? The views of women experiencing abortion in Britain during the pandemic.

BACKGROUND: During the COVID-19 pandemic, the British governments issued temporary approvals enabling the use of both medical abortion pills, mifepristone and misoprostol, at home. This permitted the introduction of a fully telemedical model of abortion care with consultations taking place via telephone or video call and medications delivered to women's homes. The decision was taken by the governments in England and Wales to continue this model of care beyond the original end date of April 2022, while at time of writing the approval in Scotland remains under consultation. METHODS: We interviewed 30 women who had undergone an abortion in England, Scotland or Wales between August and December 2021. We explored their views on the changes in abortion service configuration during the pandemic and whether abortion via telemedicine and use of abortion medications at home should continue. RESULTS: Support for continuation of the permission to use mifepristone and misoprostol at home was overwhelmingly positive. Reasons cited included convenience, comfort, reduced stigma, privacy and respect for autonomy. A telemedical model was also highly regarded for similar reasons, but for some its necessity was linked to safety measures during the pandemic, and an option to have an in-person interaction with a health professional at some point in the care pathway was endorsed. CONCLUSIONS: The approval to use abortion pills at home via telemedicine is supported by women having abortions in Britain. The voices of patients are essential to shaping acceptable and appropriate abortion service provision.

Contraception in Person-Contraception Online (CiP-CO) cohort study.

BACKGROUND: Online contraception services increasingly provide information, clinical assessment and home-delivered oral contraceptives (OCs). Evidence is lacking on the effects of online contraceptive service use on short-term contraceptive continuation. METHODS: Cohort study comparing contraceptive continuation between new users of a free-to-access online OC service in South East London with those from other, face-to-face services in the same area. Online questionnaires collected data on participants' sociodemographic characteristics, motivations for OC access, service ratings, OC knowledge and contraceptive use. Contraceptive use in the 4-month study period was measured using health service records. Unadjusted and multivariable logistic regression models compared outcomes between the online service group and those using other services. RESULTS: Online service-users (n=138) were more likely to experience short-term continuation of OCs compared with participants using other services (n=98) after adjusting for sociodemographic and other characteristics (adjusted OR 2.94, 95% CI 1.52 to 5.70). Online service-users rated their service more highly (mean 25.22, SD 3.77) than the other services group (mean 22.70, SD 4.35; p<0.001), valuing convenience and speed of access. Among progestogen-only pill users, knowledge scores were higher for the online group (mean 4.83, SD 1.90) than the other services group (mean 3.87, SD 1.73; p=0.007). Among combined oral contraceptive users, knowledge scores were similar between groups. CONCLUSIONS: Free-to-access, online contraception has the potential to improve short-term continuation of OCs. Further research using a larger study population and analysis of longer-term outcomes are required to understand the impact of online services on unintended pregnancy.

Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.

BACKGROUND: Cardiovascular disease (CVD) is a major cause of disability and mortality globally. Premature fatal and non-fatal CVD is considered to be largely preventable through the control of risk factors by lifestyle modifications and preventive medication. Lipid-lowering and antihypertensive drug therapies for primary prevention are cost-effective in reducing CVD morbidity and mortality among high-risk people and are recommended by international guidelines. However, adherence to medication prescribed for the prevention of CVD can be poor. Approximately 9% of CVD cases in the EU are attributed to poor adherence to vascular medications. Low-cost, scalable interventions to improve adherence to medications for the primary prevention of CVD have potential to reduce morbidity, mortality and healthcare costs associated with CVD. OBJECTIVES: To establish the effectiveness of interventions delivered by mobile phone to improve adherence to medication prescribed for the primary prevention of CVD in adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two other databases on 7 January 2020. We also searched two clinical trials registers on 5 February 2020. We searched reference lists of relevant papers. We applied no language or date restrictions. SELECTION CRITERIA: We included randomised controlled trials investigating interventions delivered wholly or partly by mobile phones to improve adherence to cardiovascular medications prescribed for the primary prevention of CVD. We only included trials with a minimum of one-year follow-up in order that the outcome measures related to longer-term, sustained medication adherence behaviours and outcomes. Eligible comparators were usual care or control groups receiving no mobile phone-delivered component of the intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. The main outcomes of interest were objective measures of medication adherence (blood pressure (BP) and cholesterol), CVD events, and adverse events. We contacted study authors for further information when this was not reported. MAIN RESULTS: We included 14 trials with 25,633 randomised participants. Participants were recruited from community-based primary and tertiary care or outpatient clinics. The interventions varied widely from those delivered solely through short messaging service (SMS) to those involving a combination of modes of delivery, such as SMS in addition to healthcare worker training, face-to-face counselling, electronic pillboxes, written materials, and home blood pressure monitors. Some interventions only targeted medication adherence, while others additionally targeted lifestyle changes such as diet and exercise. Due to heterogeneity in the nature and delivery of the interventions and study populations, we reported most results narratively, with the exception of two trials which were similar enough to meaningfully pool in meta-analyses. The body of evidence for the effect of mobile phone-based interventions on objective outcomes of adherence (BP and cholesterol) was of low certainty, due to most trials being at high risk of bias, and inconsistency in outcome effects. Two trials were at low risk of bias. Among five trials (total study enrolment: 5441 participants) recording low-density lipoprotein cholesterol (LDL-C), two studies found evidence for a small beneficial intervention effect on reducing LDL-C (-5.30 mg/dL, 95% confidence interval (CI) -8.30 to -2.30; and -9.20 mg/dL, 95% CI -17.70 to -0.70). The other three studies found results varying from a small reduction (-7.7 mg/dL) to a small increase in LDL-C (0.77 mg/dL). All of which had wide confidence intervals that included no effect. Across 13 studies (25,166 participants) measuring systolic blood pressure, effect estimates ranged from a large reduction (MD -12.45 mmHg, 95% CI -15.02 to -9.88) to a small increase (MD 2.80 mmHg, 95% CI 0.30 to 5.30). We found a similar range of effect estimates for diastolic BP, ranging from -12.23 mmHg (95% CI 14.03 to -10.43) to 1.64 mmHg (95% CI -0.55 to 3.83) (11 trials, 19,716 participants). Four trials showed intervention benefits for systolic and diastolic BP with confidence intervals excluding no effect, and among these were all three of the trials evaluating self-monitoring of blood pressure with mobile phone-based telemedicine. The fourth trial included SMS and provider support (with additional varied features). Seven studies (19,185 participants) reported 'controlled' BP as an outcome, and intervention effect estimates varied from negligible effects (odds ratio (OR) 1.01, 95% CI 0.76 to 1.34) to large improvements in BP control (OR 2.41, 95% CI: 1.57 to 3.68). The three trials of clinician training or decision support combined with SMS (with additional varied features) had confidence intervals encompassing benefits and harms, with point estimates close to zero. Pooled analyses of the two trials of interventions solely delivered through SMS were indicative of little or no beneficial intervention effect on systolic BP (MD -1.55 mmHg, 95% CI -3.36 to 0.25; I2 = 0%) and small increases in controlled BP (OR 1.32, 95% CI 1.06 to 1.65; I2 = 0%). Based on four studies (12,439 participants), there was very low-certainty evidence (downgraded twice for imprecision and once for risk of bias) relating to the intervention effect on combined (fatal and non-fatal) CVD events. Two studies (2535 participants) provided low-certainty evidence for the effect of the intervention on cognitive outcomes, with little or no difference between trial arms for perceived quality of care and satisfaction with treatment. There was moderate-certainty evidence (downgraded due to risk of bias) that the interventions did not cause harm, based on six studies (8285 participants). Three studies reported no adverse events attributable to the intervention. One study reported no difference between groups in experience of adverse effects of statins, and that no participants reported intervention-related adverse events. One study stated that potential side effects were similar between groups. One study reported a similar number of deaths in each arm, but did not provide further information relating to potential adverse events. AUTHORS' CONCLUSIONS: There is low-certainty evidence on the effects of mobile phone-delivered interventions to increase adherence to medication prescribed for the primary prevention of CVD. Trials of BP self-monitoring with mobile-phone telemedicine support reported modest benefits. One trial at low risk of bias reported modest reductions in LDL cholesterol but no benefits for BP. There is moderate-certainty evidence that these interventions do not result in harm. Further trials of these interventions are warranted.

Sexual health interventions delivered to participants by mobile technology: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: The use of mobile technologies to prevent STIs is recognised as a promising approach worldwide; however, evidence has been inconclusive, and the field has developed rapidly. With about 1 million new STIs a day globally, up-to-date evidence is urgently needed. OBJECTIVE: To assess the effectiveness of mobile health interventions delivered to participants for preventing STIs and promoting preventive behaviour. METHODS: We searched seven databases and reference lists of 49 related reviews (January 1990-February 2020) and contacted experts in the field. We included randomised controlled trials of mobile interventions delivered to adolescents and adults to prevent sexual transmission of STIs. We conducted meta-analyses and assessed risk of bias and certainty of evidence following Cochrane guidance. RESULTS: After double screening 6683 records, we included 22 trials into the systematic review and 20 into meta-analyses; 18 trials used text messages, 3 used smartphone applications and 1 used Facebook messages as delivery modes. The certainty of evidence regarding intervention effects on STI/HIV occurrence and adverse events was low or very low. There was moderate certainty of evidence that in the short/medium-term text messaging interventions had little or no effect on condom use (standardised mean differences (SMD) 0.02, 95% CI -0.09 to 0.14, nine trials), but increased STI/HIV testing (OR 1.83, 95% CI 1.41 to 2.36, seven trials), although not if the standard-of-care control already contained an active text messaging component (OR 1.00, 95% CI 0.68 to 1.47, two trials). Smartphone application messages also increased STI/HIV testing (risk ratio 1.40, 95% CI 1.22 to 1.60, subgroup analysis, two trials). The effects on other outcomes or of social media or blended interventions is uncertain due to low or very low certainty evidence. CONCLUSIONS: Text messaging interventions probably increase STI/HIV testing but not condom use in the short/medium term. Ongoing trials will report the effects on biological and other outcomes.

Targeted client communication via mobile devices for improving maternal, neonatal, and child health.

BACKGROUND: The global burden of poor maternal, neonatal, and child health (MNCH) accounts for more than a quarter of healthy years of life lost worldwide. Targeted client communication (TCC) via mobile devices (MD) (TCCMD) may be a useful strategy to improve MNCH. OBJECTIVES: To assess the effects of TCC via MD on health behaviour, service use, health, and well-being for MNCH. SEARCH METHODS: In July/August 2017, we searched five databases including The Cochrane Central Register of Controlled Trials, MEDLINE and Embase. We also searched two trial registries. A search update was carried out in July 2019 and potentially relevant studies are awaiting classification. SELECTION CRITERIA: We included randomised controlled trials that assessed TCC via MD to improve MNCH behaviour, service use, health, and well-being. Eligible comparators were usual care/no intervention, non-digital TCC, and digital non-targeted client communication. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane, although data extraction and risk of bias assessments were carried out by one person only and cross-checked by a second. MAIN RESULTS: We included 27 trials (17,463 participants). Trial populations were: pregnant and postpartum women (11 trials conducted in low-, middle- or high-income countries (LMHIC); pregnant and postpartum women living with HIV (three trials carried out in one lower middle-income country); and parents of children under the age of five years (13 trials conducted in LMHIC). Most interventions (18) were delivered via text messages alone, one was delivered through voice calls only, and the rest were delivered through combinations of different communication channels, such as multimedia messages and voice calls. Pregnant and postpartum women TCCMD versus standard care For behaviours, TCCMD may increase exclusive breastfeeding in settings where rates of exclusive breastfeeding are less common (risk ratio (RR) 1.30, 95% confidence intervals (CI) 1.06 to 1.59; low-certainty evidence), but have little or no effect in settings where almost all women breastfeed (low-certainty evidence). For use of health services, TCCMD may increase antenatal appointment attendance (odds ratio (OR) 1.54, 95% CI 0.80 to 2.96; low-certainty evidence); however, the CI encompasses both benefit and harm. The intervention may increase skilled attendants at birth in settings where a lack of skilled attendants at birth is common (though this differed by urban/rural residence), but may make no difference in settings where almost all women already have a skilled attendant at birth (OR 1.00, 95% CI 0.34 to 2.94; low-certainty evidence). There were uncertain effects on maternal and neonatal mortality and morbidity because the certainty of the evidence was assessed as very low. TCCMD versus non-digital TCC (e.g. pamphlets) TCCMD may have little or no effect on exclusive breastfeeding (RR 0.92, 95% CI 0.79 to 1.07; low-certainty evidence). TCCMD may reduce 'any maternal health problem' (RR 0.19, 95% CI 0.04 to 0.79) and 'any newborn health problem' (RR 0.52, 95% CI 0.25 to 1.06) reported up to 10 days postpartum (low-certainty evidence), though the CI for the latter includes benefit and harm. The effect on health service use is unknown due to a lack of studies. TCCMD versus digital non-targeted communication No studies reported behavioural, health, or well-being outcomes for this comparison. For use of health services, there are uncertain effects for the presence of a skilled attendant at birth due to very low-certainty evidence, and the intervention may make little or no difference to attendance for antenatal influenza vaccination (RR 1.05, 95% CI 0.71 to 1.58), though the CI encompasses both benefit and harm (low-certainty evidence). Pregnant and postpartum women living with HIV TCCMD versus standard care For behaviours, TCCMD may make little or no difference to maternal and infant adherence to antiretroviral (ARV) therapy (low-certainty evidence). For health service use, TCC mobile telephone reminders may increase use of antenatal care slightly (mean difference (MD) 1.5, 95% CI -0.36 to 3.36; low-certainty evidence). The effect on the proportion of births occurring in a health facility is uncertain due to very low-certainty evidence. For health and well-being outcomes, there was an uncertain intervention effect on neonatal death or stillbirth, and infant HIV due to very low-certainty evidence. No studies reported on maternal mortality or morbidity. TCCMD versus non-digital TCC The effect is unknown due to lack of studies reporting this comparison. TCCMD versus digital non-targeted communication TCCMD may increase infant ARV/prevention of mother-to-child transmission treatment adherence (RR 1.26, 95% CI 1.07 to 1.48; low-certainty evidence). The effect on other outcomes is unknown due to lack of studies. Parents of children aged less than five years No studies reported on correct treatment, nutritional, or health outcomes. TCCMD versus standard care Based on 10 trials, TCCMD may modestly increase health service use (vaccinations and HIV care) (RR 1.21, 95% CI 1.08 to 1.34; low-certainty evidence); however, the effect estimates varied widely between studies. TCCMD versus non-digital TCC TCCMD may increase attendance for vaccinations (RR 1.13, 95% CI 1.00 to 1.28; low-certainty evidence), and may make little or no difference to oral hygiene practices (low-certainty evidence). TCCMD versus digital non-targeted communication TCCMD may reduce attendance for vaccinations, but the CI encompasses both benefit and harm (RR 0.63, 95% CI 0.33 to 1.20; low-certainty evidence). No trials in any population reported data on unintended consequences. AUTHORS' CONCLUSIONS: The effect of TCCMD for most outcomes is uncertain. There may be improvements for some outcomes using targeted communication but these findings were of low certainty. High-quality, adequately powered trials and cost-effectiveness analyses are required to reliably ascertain the effects and relative benefits of TCCMD. Future studies should measure potential unintended consequences, such as partner violence or breaches of confidentiality.

Targeted client communication via mobile devices for improving sexual and reproductive health.

BACKGROUND: The burden of poor sexual and reproductive health (SRH) worldwide is substantial, disproportionately affecting those living in low- and middle-income countries. Targeted client communication (TCC) delivered via mobile devices (MD) (TCCMD) may improve the health behaviours and service use important for sexual and reproductive health. OBJECTIVES: To assess the effects of TCC via MD on adolescents' knowledge, and on adolescents' and adults' sexual and reproductive health behaviour, health service use, and health and well-being. SEARCH METHODS: In July/August 2017, we searched five databases including The Cochrane Central Register of Controlled Trials, MEDLINE and Embase. We also searched two trial registries. A search update was carried out in July 2019 and potentially relevant studies are awaiting classification. SELECTION CRITERIA: We included randomised controlled trials of TCC via MD to improve sexual and reproductive health behaviour, health service use, and health and well-being. Eligible comparators were standard care or no intervention, non-digital TCC, and digital non-targeted communication. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane, although data extraction and risk of bias assessments were carried out by one person only and cross-checked by a second. We have presented results separately for adult and adolescent populations, and for each comparison. MAIN RESULTS: We included 40 trials (27 among adult populations and 13 among adolescent populations) with a total of 26,854 participants. All but one of the trials among adolescent populations were conducted in high-income countries. Trials among adult populations were conducted in a range of high- to low-income countries. Among adolescents, nine interventions were delivered solely through text messages; four interventions tested text messages in combination with another communication channel, such as emails, multimedia messaging, or voice calls; and one intervention used voice calls alone. Among adults, 20 interventions were delivered through text messages; two through a combination of text messages and voice calls; and the rest were delivered through other channels such as voice calls, multimedia messaging, interactive voice response, and instant messaging services. Adolescent populations TCCMD versus standard care TCCMD may increase sexual health knowledge (risk ratio (RR) 1.45, 95% confidence interval (CI) 1.23 to 1.71; low-certainty evidence). TCCMD may modestly increase contraception use (RR 1.19, 95% CI 1.05 to 1.35; low-certainty evidence). The effects on condom use, antiretroviral therapy (ART) adherence, and health service use are uncertain due to very low-certainty evidence. The effects on abortion and STI rates are unknown due to lack of studies. TCCMD versus non-digital TCC (e.g. pamphlets) The effects of TCCMD on behaviour (contraception use, condom use, ART adherence), service use, health and wellbeing (abortion and STI rates) are unknown due to lack of studies for this comparison. TCCMD versus digital non-targeted communication The effects on sexual health knowledge, condom and contraceptive use are uncertain due to very low-certainty evidence. Interventions may increase health service use (attendance for STI/HIV testing, RR 1.61, 95% CI 1.08 to 2.40; low-certainty evidence). The intervention may be beneficial for reducing STI rates (RR 0.61, 95% CI 0.28 to 1.33; low-certainty evidence), but the confidence interval encompasses both benefit and harm. The effects on abortion rates and on ART adherence are unknown due to lack of studies. We are uncertain whether TCCMD results in unintended consequences due to lack of evidence. Adult populations TCCMD versus standard care For health behaviours, TCCMD may modestly increase contraception use at 12 months (RR 1.17, 95% CI 0.92 to 1.48) and may reduce repeat abortion (RR 0.68 95% CI 0.28 to 1.66), though the confidence interval encompasses benefit and harm (low-certainty evidence). The effect on condom use is uncertain. No study measured the impact of this intervention on STI rates. TCCMD may modestly increase ART adherence (RR 1.13, 95% CI 0.97 to 1.32, low-certainty evidence, and standardised mean difference 0.44, 95% CI -0.14 to 1.02, low-certainty evidence). TCCMD may modestly increase health service utilisation (RR 1.17, 95% CI 1.04 to 1.31; low-certainty evidence), but there was substantial heterogeneity (I2 = 85%), with mixed results according to type of service utilisation (i.e. attendance for STI testing; HIV treatment; voluntary male medical circumcision (VMMC); VMMC post-operative visit; post-abortion care). For health and well-being outcomes, there may be little or no effect on CD4 count (mean difference 13.99, 95% CI -8.65 to 36.63; low-certainty evidence) and a slight reduction in virological failure (RR 0.86, 95% CI 0.73 to 1.01; low-certainty evidence). TCCMD versus non-digital TCC No studies reported STI rates, condom use, ART adherence, abortion rates, or contraceptive use as outcomes for this comparison. TCCMD may modestly increase in service attendance overall (RR: 1.12, 95% CI 0.92-1.35, low certainty evidence), however the confidence interval encompasses benefit and harm. TCCMD versus digital non-targeted communication No studies reported STI rates, condom use, ART adherence, abortion rates, or contraceptive use as outcomes for this comparison. TCCMD may increase service utilisation overall (RR: 1.71, 95% CI 0.67-4.38, low certainty evidence), however the confidence interval encompasses benefit and harm and there was considerable heterogeneity (I2 = 72%), with mixed results according to type of service utilisation (STI/HIV testing, and VMMC). Few studies reported on unintended consequences. One study reported that a participant withdrew from the intervention as they felt it compromised their undisclosed HIV status. AUTHORS' CONCLUSIONS: TCCMD may improve some outcomes but the evidence is of low certainty. The effect on most outcomes is uncertain/unknown due to very low certainty evidence or lack of evidence. High quality, adequately powered trials and cost effectiveness analyses are required to reliably ascertain the effects and relative benefits of TCC delivered by mobile devices. Given the sensitivity and stigma associated with sexual and reproductive health future studies should measure unintended consequences, such as partner violence or breaches of confidentiality.

A cohort study of the service-users of online contraception.

BACKGROUND: In January 2017, the first free service providing oral contraceptive pills (OCPs) ordered online and posted home became available in the London boroughs of Lambeth and Southwark - ethnically and socioeconomically diverse areas with high rates of unplanned pregnancy. There are concerns that online services can increase health inequalities; therefore, we aimed to describe service-users according to age, ethnicity and Index of Multiple Deprivation (IMD) quintile of area of residence and to examine the association of these with repeated use. METHODS: We analysed routinely collected data from January 2017 to April 2018 and described service-users using available sociodemographic factors and information on patterns of use. Logistic regression analysis examined factors associated with repeat ordering of OCPs. RESULTS: The service was accessed by 726 individuals; most aged between 20 and 29 years (72.5%); self-identified as being of white ethnic group (58.8%); and residents of the first and second most deprived IMD quintiles (79.2%). Compared with those of white ethnic group, those of black ethnic group were significantly less likely to make repeat orders (adjusted OR 0.53, 95% CI 0.31 to 0.89; p=0.001), as were those of Asian and mixed ethnic groups. CONCLUSIONS: These are the first empirical findings on free, online contraception and suggest that early adopters broadly reflect the population of the local area in terms of ethnic diversity and deprivation as measured by IMD. Ongoing service development should prioritise the identification and removal of barriers which may inhibit repeat use for black and minority ethnic groups.

Safetxt: a safer sex intervention delivered by mobile phone messaging on sexually transmitted infections (STI) among young people in the UK - protocol for a randomised controlled trial.

INTRODUCTION: Young people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic pregnancy, particularly among those with repeated infections. We developed the safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing among young people in the UK. METHODS AND ANALYSIS: A single-blind randomised trial to reliably establish the effect of the safetxt intervention on chlamydia and gonorrhoea infection at 1 year. We will recruit 6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK. Participants will be allocated to receive the safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system. The primary outcome will be the cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests. Secondary outcomes include partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners. ETHICS AND DISSEMINATION: Ethics approval was obtained from NHS Health Research Authority - London - Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine. We will submit the results of the trial for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: International Standard Randomised Controlled Trials Number: ISRCTN64390461. Registered on 17th March 2016. WHO trial registration data set available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461. TRIAL PROTOCOL VERSION: 12, 19th July 2018.

Trends in sexual activity and demand for and use of modern contraceptive methods in 74 countries: a retrospective analysis of nationally representative surveys.

BACKGROUND: A quarter of a century ago, two global events-the International Conference on Population and Development in Cairo, and the Fourth World Conference on Women in Beijing-placed gender equality and reproductive health and rights at the centre of the development agenda. Progress towards these goals has been slower than hoped. We used survey data and national-level indicators of social determinants from 74 countries to examine change in satisfaction of contraceptive need from a contextual perspective. METHODS: We searched for individual-level data from repeated nationally representative surveys that included information on sexual and reproductive health, and created a single dataset by harmonising data from each survey to a standard data specification. We described the relative timings of sexual initiation, first union (cohabitation or marriage), and first birth and used logistic regression to show the change in prevalence of sexual activity, demand for contraception, and modern contraceptive use. We used linear regression to examine country-level associations between the gender development index and the expected length of time in education for women and the three outcomes: sexual activity, demand for contraception, and modern contraceptive use. We used principal component analysis to describe countries using a combination of social-structural and behavioural indicators and assessed how well the components explained country-level variation in the proportion of women using contraception with fractional logistic regression. FINDINGS: In 34 of the 74 countries examined, proportions of all women who were sexually active, not wanting to conceive, and not using a modern contraceptive method decreased over time. Proportions of women who had been sexually active in the past year changed over time in 43 countries, with increases in 30 countries; demand for contraception increased in 42 countries, and use of a modern method of contraception increased in 37 countries. Increases over time in met need for contraception were correlated with increases in gender equality and with women's time in education. Regression analysis on the principal components showed that country-level variation in met contraceptive need was largely explained by a single component that combined behavioural and social-contextual variables. INTERPRETATION: Progress towards satisfying demand for contraception should take account of the changing context in which it is practised. To remove the remaining barriers, policy responses-and therefore research priorities-could require a stronger focus on social-structural determinants and broader aspects of sexual health. FUNDING: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

Help-seeking for genitourinary symptoms: a mixed methods study from Britain's Third National Survey of Sexual Attitudes and Lifestyles (Natsal-3).

OBJECTIVES: Quantify non-attendance at sexual health clinics and explore help-seeking strategies for genitourinary symptoms. DESIGN: Sequential mixed methods using survey data and semistructured interviews. SETTING: General population in Britain. PARTICIPANTS: 1403 participants (1182 women) from Britain's Third National Survey of Sexual Attitudes and Lifestyles (Natsal-3; undertaken 2010-2012), aged 16-44 years who experienced specific genitourinary symptoms (past 4 weeks), of whom 27 (16 women) who reported they had never attended a sexual health clinic also participated in semistructured interviews, conducted May 2014-March 2015. PRIMARY AND SECONDARY OUTCOME MEASURES: From survey data, non-attendance at sexual health clinic (past year) and preferred service for STI care; semistructured interview domains were STI social representations, symptom experiences, help-seeking responses and STI stigma. RESULTS: Most women (85.9% (95% CI 83.7 to 87.9)) and men (87.6% (95% CI 82.3 to 91.5)) who reported genitourinary symptoms in Natsal-3 had not attended a sexual health clinic in the past year. Around half of these participants cited general practice (GP) as their preferred hypothetical service for STI care (women: 58.5% (95% CI 55.2% to 61.6%); men: 54.3% (95% CI 47.1% to 61.3%)). Semistructured interviews elucidated four main responses to symptoms: not seeking healthcare, seeking information to self-diagnose and self-treat, seeking care at non-specialist services and seeking care at sexual health clinics. Collectively, responses suggested individuals sought to gain control over their symptoms, and they prioritised emotional reassurance over accessing medical expertise. Integrating survey and interview data strengthened the evidence that participants preferred their general practitioner for STI care and extended understanding of help-seeking strategies. CONCLUSIONS: Help-seeking is important to access appropriate healthcare for genitourinary symptoms. Most participants did not attend a sexual health clinic but sought help from other sources. This study supports current service provision options in Britain, facilitating individual autonomy about where to seek help.

Changes in, and factors associated with, frequency of sex in Britain: evidence from three National Surveys of Sexual Attitudes and Lifestyles (Natsal).

OBJECTIVES: To examine changes over time in the reported frequency of occurrence of sex and associations between sexual frequency and selected variables. DESIGN: Repeat, cross sectional, population based National Surveys of Sexual Attitudes and Lifestyles (Natsal-1, Natsal-2, and Natsal-3). SETTING: British general population. PARTICIPANTS: 18 876 men and women aged 16-59 and resident in Britain were interviewed in Natsal-1, completed in 1991; 11 161 aged 16-44 years in Natsal-2, completed in 2001, and 15 162 aged 16-74 years in Natsal-3, completed in 2012. Comparisons of actual and preferred sexual frequency in men and women aged 16-44 (the age range common to all surveys) between the three surveys. Factors associated with sexual frequency of at least once a week were examined using Natsal-3 data. MAIN OUTCOME MEASURES: Sexual activity in the past month; frequency of sex in the past month; preferred frequency of sex. RESULTS: Median number of occasions of sex in the past month was four in Natsal-1 and Natsal-2 and three in Natsal-3 among women; and three in Natsal-1, Natsal-2, and Natsal-3 among men. The proportion reporting no sex in the past month fell between Natsal-1 and Natsal-2 (from 28.5% to 23.0% in women and from 30.9% to 26.0% in men) but increased significantly in Natsal-3 (to 29.3% in women and 29.2% in men). The proportion reporting sex 10 times or more in the past month increased between Natsal-1 and Natsal-2, from 18.4% to 20.6% in women and from 19.9% to 20.2% in men, but fell in Natsal-3, to 13.2% in woman and 14.4% in men. Participants aged 25 and over, and those married or cohabiting, experienced the steepest declines in sexual frequency (P values for interaction <0.05). Alongside the declines in sexual frequency, there was an increase in the proportion reporting that they would prefer sex more often. Age adjusted odds ratios showed that men and women in better physical and mental health had sex more frequently, as did those who were fully employed and those with higher earnings. CONCLUSIONS: Frequency of sex has declined recently in Britain, more markedly among those in early middle age and those who are married or cohabiting. The findings and their implications need to be explained in the context of technological, demographic, and social change in Britain and warrant further investigation.

Prevalence and correlates of 'sexual competence' at first heterosexual intercourse among young people in Britain.

BACKGROUND: A greater understanding of the circumstances of first sexual intercourse, as opposed to an exclusive focus on age at occurrence, is required in order that sexual health and well-being can be promoted from the onset of sexual activity. METHODS: We used data from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3) conducted in Britain. Participants were categorised as 'sexually competent' at first heterosexual intercourse if the following self-reported criteria applied to the event: contraceptive use, autonomy of decision, both partners 'equally willing', and occurrence at the perceived 'right time'. We examined the prevalence of 'sexual competence', and its component parts, by age at first intercourse among 17-24-year-olds. Using multivariable logistic regression, we explored associations between sexual competence and potential explanatory factors. RESULTS: Variation in 'sexual competence' and its component parts was associated with, but not fully explained by, age at first sex: 22.4% and 36.2% of men and women who had first sex at age 13-14 years were categorised as 'sexually competent', rising to 63.7% and 60.4% among those aged ≥18 years at first intercourse. Lack of sexual competence was independently associated with: first intercourse before the age of 16 years, area-level deprivation (men only), lower educational level, black ethnicity (women only), reporting 'friends' as main source of learning about sex (women only), non-'steady' relationship at first sex, and uncertainty of first partner's virginity status. CONCLUSIONS: A substantial proportion of young people in Britain transition into sexual activity under circumstances incompatible with positive sexual health. Social inequalities in sexual health are reflected in the context of first intercourse.

Contraceptive method use among women and its association with age, relationship status and duration: findings from the third British National Survey of Sexual Attitudes and Lifestyles (Natsal-3).

BACKGROUND: One in six pregnancies in Britain are unplanned. An understanding of influences on contraceptive method choice is essential to provision compatible with users' lifestyles. This study describes contraceptive method use by age, and relationship status and duration, among women in Britain. METHODS: Data from women participating in the third British National Survey of Sexual Attitudes and Lifestyles were used to describe contraceptive use grouped as: unreliable method or none; barrier methods; oral/injectable hormonal methods; and long-acting reversible contraception. A total of 4456 women at risk of pregnancy were used to examine associations between contraception use, age, relationship type and duration. Age-stratified odds ratios for contraceptive use by relationship type and duration were estimated using binary logistic regression. RESULTS: Some 26.0% of 16-49-year-olds used hormonal contraception as their usual method. Use of hormonal and barrier methods was highest in the youngest age group and decreased with age; the reverse was true for use of unreliable methods or none. Barrier method use was higher in short-term relationships among younger participants; this was not seen among older respondents. Duration was more strongly associated with usual contraceptive method than relationship type; this pattern was more marked among younger participants. CONCLUSIONS: Asking about relationship status and duration may help providers support women's contraceptive use by considering their priorities and preferences at different life stages. Interactions between relationship characteristics, age and contraception are complex, and bear closer scrutiny both in research and in policy and practice.

Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.

BACKGROUND: Cardiovascular disease (CVD) is a major cause of disability and mortality globally. Premature fatal and non-fatal CVD is considered to be largely preventable through the control of risk factors via lifestyle modifications and preventive medication. Lipid-lowering and antihypertensive drug therapies for primary prevention are cost-effective in reducing CVD morbidity and mortality among high-risk people and are recommended by international guidelines. However, adherence to medication prescribed for the prevention of CVD can be poor. Approximately 9% of CVD cases in the EU are attributed to poor adherence to vascular medications. Low-cost, scalable interventions to improve adherence to medications for the primary prevention of CVD have potential to reduce morbidity, mortality and healthcare costs associated with CVD. OBJECTIVES: To establish the effectiveness of interventions delivered by mobile phone to improve adherence to medication prescribed for the primary prevention of CVD in adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two other databases on 21 June 2017 and two clinical trial registries on 14 July 2017. We searched reference lists of relevant papers. We applied no language or date restrictions. SELECTION CRITERIA: We included randomised controlled trials investigating interventions delivered wholly or partly by mobile phones to improve adherence to cardiovascular medications prescribed for the primary prevention of CVD. We only included trials with a minimum of one-year follow-up in order that the outcome measures related to longer-term, sustained medication adherence behaviours and outcomes. Eligible comparators were usual care or control groups receiving no mobile phone-delivered component of the intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. We contacted study authors for disaggregated data when trials included a subset of eligible participants. MAIN RESULTS: We included four trials with 2429 randomised participants. Participants were recruited from community-based primary care or outpatient clinics in high-income (Canada, Spain) and upper- to middle-income countries (South Africa, China). The interventions received varied widely; one trial evaluated an intervention focused on blood pressure medication adherence delivered solely through short messaging service (SMS), and one intervention involved blood pressure monitoring combined with feedback delivered via smartphone. Two trials involved interventions which targeted a combination of lifestyle modifications, alongside CVD medication adherence, one of which was delivered through text messages, written information pamphlets and self-completion cards for participants, and the other through a multi-component intervention comprising of text messages, a computerised CVD risk evaluation and face-to-face counselling. Due to heterogeneity in the nature and delivery of the interventions, we did not conduct a meta-analysis, and therefore reported results narratively.We judged the body of evidence for the effect of mobile phone-based interventions on objective outcomes (blood pressure and cholesterol) of low quality due to all included trials being at high risk of bias, and inconsistency in outcome effects. Of two trials targeting medication adherence alongside other lifestyle modifications, one reported a small beneficial intervention effect in reducing low-density lipoprotein cholesterol (mean difference (MD) -9.2 mg/dL, 95% confidence interval (CI) -17.70 to -0.70; 304 participants), and the other found no benefit (MD 0.77 mg/dL, 95% CI -4.64 to 6.18; 589 participants). One trial (1372 participants) of a text messaging-based intervention targeting adherence showed a small reduction in systolic blood pressure (SBP) for the intervention arm which delivered information-only text messages (MD -2.2 mmHg, 95% CI -4.4 to -0.04), but uncertain evidence of benefit for the second intervention arm that provided additional interactivity (MD -1.6 mmHg, 95% CI -3.7 to 0.5). One study examined the effect of blood pressure monitoring combined with smartphone messaging, and reported moderate intervention benefits on SBP and diastolic blood pressure (DBP) (SBP: MD -7.10 mmHg, 95% CI -11.61 to -2.59; DBP: -3.90 mmHg, 95% CI -6.45 to -1.35; 105 participants). There was mixed evidence from trials targeting medication adherence alongside lifestyle advice using multi-component interventions. One trial found large benefits for SBP and DBP (SBP: MD -12.45 mmHg, 95% CI -15.02 to -9.88; DBP: MD -12.23 mmHg, 95% CI -14.03 to -10.43; 589 participants), whereas the other trial demonstrated no beneficial effects on SBP or DBP (SBP: MD 0.83 mmHg, 95% CI -2.67 to 4.33; DBP: MD 1.64 mmHg, 95% CI -0.55 to 3.83; 304 participants).Two trials reported on adverse events and provided low-quality evidence that the interventions did not cause harm. One study provided low-quality evidence that there was no intervention effect on reported satisfaction with treatment.Two trials were conducted in high-income countries, and two in upper- to middle-income countries. The interventions evaluated employed between three and 16 behaviour change techniques according to coding using Michie's taxonomic method. Two trials evaluated interventions that involved potential users in their development. AUTHORS' CONCLUSIONS: There is low-quality evidence relating to the effects of mobile phone-delivered interventions to increase adherence to medication prescribed for the primary prevention of CVD; some trials reported small benefits while others found no effect. There is low-quality evidence that these interventions do not result in harm. On the basis of this review, there is currently uncertainty around the effectiveness of these interventions. We identified six ongoing trials being conducted in a range of contexts including low-income settings with potential to generate more precise estimates of the effect of primary prevention medication adherence interventions delivered by mobile phone.