Increasing HIV testing and linkage to care among men in rural South Africa using conditional financial incentives and a decision support app: A process evaluation.

Men in sub-Saharan Africa are less likely to accept HIV testing and link to HIV care than women. We conducted a trial to investigate the impact of conditional financial incentives and a decision support application, called EPIC-HIV, on HIV testing and linkage to care. We report the findings of the trial process evaluation to explore whether the interventions were delivered as intended, identify mechanisms of impact and any contextual factors that may have impacted the trial outcomes. Between August 2018 and March 2019, we conducted in-depth interviews and focus group discussions with trial participants (n = 31) and staff (n = 14) to examine views on the implementation process, participant responses to the interventions and the external factors that may have impacted the implementation and outcomes of the study. Interviews were audio-recorded, transcribed, and translated where necessary, and thematically analyzed using ATLAS-ti and NVivo. Both interventions were perceived to be acceptable and useful by participants and implementers. EPIC-HIV proved challenging to implement as intended because it was difficult to ensure consistent use of earphones, and maintenance of privacy. Some participants struggled to navigate the EPIC-HIV app independently and select stories that appealed to them without support. Some participants stopped exploring the app before the end, resulting in an incomplete use of EPIC-HIV. While the financial incentive was implemented as intended, there were challenges with eligibility. The convenience and privacy of home testing influenced the uptake of HIV testing. Contextual barriers including fear of HIV stigma and disclosure if diagnosed with HIV, and expectations of poor treatment in clinics may have inhibited linkage to care. Financial incentives were relatively straightforward to implement and increased uptake of home-based rapid HIV testing but were not sufficient as a 'stand-alone' intervention. Barriers like fear of stigma should be addressed to facilitate linkage to care.

Population impacts of conditional financial incentives and a male-targeted digital decision support application on the HIV treatment cascade in rural KwaZulu Natal: findings from the HITS cluster randomized clinical trial.

INTRODUCTION: In South Africa, the HIV care cascade remains suboptimal. We investigated the impact of small conditional financial incentives (CFIs) and male-targeted HIV-specific decision-support application (EPIC-HIV) on the HIV care cascade. METHODS: In 2018, in uMkhanyakude district, 45 communities were randomly assigned to one of four arms: (i) CFI for home-based HIV testing and linkage to care within 6 weeks (R50 [US$3] food voucher each); (ii) EPIC-HIV which are based on self-determination theory; (iii) both CFI and EPIC-HIV; and (iv) standard of care. EPIC-HIV consisted of two components: EPIC-HIV 1, provided to men through a tablet before home-based HIV testing, and EPIC-HIV 2, offered 1 month later to men who tested positive but had not yet linked to care. Linking HITS trial data to national antiretroviral treatment (ART) programme data and HIV surveillance programme data, we estimated HIV status awareness after the HITS trial implementation, ART status 3 month after the trial and viral load suppression 1 year later. Analysis included all known individuals living with HIV in the study area including those who did not participated in the HITS trial. RESULTS: Among the 33,778 residents in the study area, 2763 men and 7266 women were identified as living with HIV by the end of the intervention period and included in the analysis. After the intervention, awareness of HIV-positive status was higher in the CFI arms compared to non-CFI arms (men: 793/908 [87.3%] vs. 1574/1855 [84.9%], RR = 1.03 [95% CI: 0.99-1.07]; women: 2259/2421 [93.3%] vs. 4439/4845 [91.6%], RR = 1.02 [95% CI: 1.00-1.04]). Three months after the intervention, no differences were found for linkage to ART between arms. One year after the intervention, only 1829 viral test results were retrieved. Viral suppression was higher but not significant in the EPIC-HIV intervention arms among men (65/99 [65.7%] vs. 182/308 [59.1%], RR = 1.11 [95% CI: 0.88-1.40]). CONCLUSIONS: Small CFIs can contribute to achieve the first step of the HIV care cascade. However, neither CFIs nor EPIC-HIV was sufficient to increase the number of people on ART. Additional evidence is needed to confirm the impact of EPIC-HIV on viral suppression.

The impact of a conditional financial incentive on linkage to HIV care: Findings from the HITS cluster randomized clinical trial in rural South Africa.

Introduction: HIV elimination requires innovative approaches to ensure testing and immediate treatment provision. We investigated the effectiveness of conditional financial incentives on increasing linkage to HIV care in a 2×2 factorial cluster randomized controlled trial-Home-Based Intervention to Test and Start (HITS) - in rural South Africa. Methods: Of 45 communities in uMkhanyakude, KwaZulu-Natal, 16 communities were randomly assigned to the arms to receive financial incentives for home-based HIV counseling and testing (HBHCT) and linkage to care within 6 weeks (R50 [US$3] food voucher each) and 29 communities to the arms without financial incentives. We examined linkage to care (i.e., initiation or resumption of antiretroviral therapy after >3 months of care interruption) at local clinics within 6 weeks of a home visit, the eligibility period to receive the second financial incentive. Linkage to care was ascertained from individual clinical records. Intention-to-treat analysis (ITT) was performed using modified Poisson regression with adjustment for receiving another intervention (i.e., male-targeted HIV-specific decision support app) and clustering of standard errors at the community level. Results: Among 13,894 eligible men (i.e., ≥15 years and resident in the 45 communities), 20.7% received HBHCT, which resulted in 122 HIV-positive tests. Of these, 27 linked to care within 6 weeks of HBHCT. Additionally, of eligible men who did not receive HBHCT, 66 linked to care. In the ITT analysis, the proportion of linkage to care among men did not differ in the arms which received financial incentives and those without financial incentives (adjusted Risk Ratio [aRR]=0.78, 95% CI: 0.51-1.21). Among 19,884 eligible women, 29.1% received HBHCT, which resulted in 375 HIV-positive tests. Of these, 75 linked to care. Among eligible women who did not receive HBHCT, 121 linked to care within 6 weeks. Women in the financial incentive arms had a significantly higher probability of linkage to care, compared to those in the arms without financial incentives (aRR=1.50; 95% CI: 1.03-2.21). Conclusion: While a small once-off financial incentive did not increase linkage to care among men during the eligibility period of 6 weeks, it significantly improved linkage to care among women over the same period. Clinical Trial Number: ClinicalTrials.gov # NCT03757104.

Impact of family networks on uptake of health interventions: evidence from a community-randomized control trial aimed at increasing HIV testing in South Africa.

INTRODUCTION: While it is widely acknowledged that family relationships can influence health outcomes, their impact on the uptake of individual health interventions is unclear. In this study, we quantified how the efficacy of a randomized health intervention is shaped by its pattern of distribution in the family network. METHODS: The "Home-Based Intervention to Test and Start" (HITS) was a 2×2 factorial community-randomized controlled trial in Umkhanyakude, KwaZulu-Natal, South Africa, embedded in the Africa Health Research Institute's population-based demographic and HIV surveillance platform (ClinicalTrials.gov # NCT03757104). The study investigated the impact of two interventions: a financial micro-incentive and a male-targeted HIV-specific decision support programme. The surveillance area was divided into 45 community clusters. Individuals aged ≥15 years in 16 randomly selected communities were offered a micro-incentive (R50 [$3] food voucher) for rapid HIV testing (intervention arm). Those living in the remaining 29 communities were offered testing only (control arm). Study data were collected between February and November 2018. Using routinely collected data on parents, conjugal partners, and co-residents, a socio-centric family network was constructed among HITS-eligible individuals. Nodes in this network represent individuals and ties represent family relationships. We estimated the effect of offering the incentive to people with and without family members who also received the offer on the uptake of HIV testing. We fitted a linear probability model with robust standard errors, accounting for clustering at the community level. RESULTS: Overall, 15,675 people participated in the HITS trial. Among those with no family members who received the offer, the incentive's efficacy was a 6.5 percentage point increase (95% CI: 5.3-7.7). The efficacy was higher among those with at least one family member who received the offer (21.1 percentage point increase (95% CI: 19.9-22.3). The difference in efficacy was statistically significant (21.1-6.5 = 14.6%; 95% CI: 9.3-19.9). CONCLUSIONS: Micro-incentives appear to have synergistic effects when distributed within family networks. These effects support family network-based approaches for the design of health interventions.

Can a conditional financial incentive (CFI) reduce socio-demographic inequalities in home-based HIV testing uptake? A secondary analysis of the HITS clinical trial intervention in rural South Africa.

In sub-Saharan Africa, home-based HIV testing interventions are designed to reach sub-populations with low access to HIV testing such as men, younger or less educated people. Combining these interventions with conditional financial incentives (CFI) has been shown to be effective to increase testing uptake. CFI are effective for one-off health behaviour change but whether they operate differentially on different socio-demographic groups is less clear. Using data from the HITS trial in South Africa, we investigated whether a CFI was able to reduce existing home-based HIV testing uptake inequalities observed by socio-demographic groups. Residents aged ≥15 years in the study area were assigned to an intervention arm (16 clusters) or a control arm (29 clusters). In the intervention arm, individuals received a food voucher (∼3.5 US dollars) if they accepted to take a home-based HIV test. Testing uptake differences were considered for socio-demographic (sex, age, education, employment status, marital status, household asset index) and geographical (urban/rural living area, distance from clinic) characteristics. Among the 37,028 residents, 24,793 (9290 men, 15,503 women) were included in the analysis. CFI increased significantly testing uptake among men (39.2% vs 25.2%, p < 0.001) and women (45.9% vs 32.0%, p < 0.001) with similar absolute increase between men and women. Uptake was higher amongst the youngest or least educated individuals, and amongst single (vs in union) or unemployed men. Absolute uptake increase was also significantly higher amongst these groups resulting in increasing socio-demographic differentials for home-based HIV testing uptake. However, because these groups are known to have less access to other public HIV testing services, CFI could reduce inequalities for HIV testing access in our specific context. Although CFI significantly increased home-based HIV testing uptake, it did not do so differentially by socio-demographic group. Future interventions using CFI should make sure that the intervention alone does not increase existing health inequities.

Reducing New Chlamydia Infection Among Young Men by Promoting Correct and Consistent Condom Use: Protocol for a Randomized Controlled Trial.

BACKGROUND: The health, social, and economic costs of sexually transmitted infections (STIs) represent a major public health concern. Young people are considered one of the groups most at risk for acquiring and transmitting STIs. Correct and consistent condom use has been shown to be the most effective method for reducing STIs; however, condoms are often not used properly. Evidence shows that brief behavior change interventions that focus on skills, communication, and motivation to acquire safe sex practices should be adopted into routine care to reduce STIs. Funding for sexual health services in England has declined dramatically, so novel ways of reducing clinic attendance are being sought. The home-based intervention strategy (HIS-UK) to promote condom use among young men has shown promise in feasibility and pilot studies by demonstrating high acceptability of the intervention in participant and health professional feedback, including aiding men to find condoms they like and feel more confident when using condoms. OBJECTIVE: The aim of this study is to determine the effectiveness and cost-effectiveness of HIS-UK when compared to usual condom distribution care among young men. METHODS: The 3 trial arms consisting of "e-HIS" (HIS-UK delivered digitally), "ProHIS" (HIS-UK delivered face-to-face), and control condition (usual National Health Service [NHS] care) will be compared against the following 3 primary outcomes: the extent to which correct and consistent condom use is increased; improvement of condom use experiences (pleasure as well as fit and feel); and decrease in chlamydia test positivity. Eligibility criteria include men aged 16-25 years at risk of STIs through reporting of condom use errors (ie, breakage or slippage) or condomless penile-vaginal or penile-anal intercourse with casual or new sexual partners during the previous 3 months. Prospective participants will be recruited through targeted advertisements and an opportunistic direct approach at selected sexual health and genitourinary medicine services and university-associated health centers and general practitioner practices. Community and educational establishments will be used to further advertise the study and signpost men to recruitment sites. Participants will be randomly allocated to 1 of 3 trial arms. A repeated measures design will assess the parallel arms with baseline and 12 monthly follow-up questionnaires after intervention and 3 chlamydia screening points (baseline, 6, and 12 months). RESULTS: Recruitment commenced in March 2020. Due to the COVID-19 pandemic, the study was halted and has since reopened for recruitment in Summer 2021. A 30-month recruitment period is planned. CONCLUSIONS: If effective and cost-effective, HIS-UK can be scaled up into routine NHS usual care to reduce both STI transmission in young people and pressure on NHS resources. This intervention may further encourage sexual health services to adopt digital technologies, allowing for them to become more widely available to young people while decreasing health inequalities and fear of stigmatization. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11400820; https://www.isrctn.com/ISRCTN11400820.

Determining the Prevalence and Incidence of SARS-CoV-2 Infection in Prisons in England: Protocol for a Repeated Panel Survey and Enhanced Outbreak Study.

BACKGROUND: There are over 80,000 people imprisoned in England and Wales in 117 prisons. The management of the COVID-19 pandemic presents particular challenges in this setting where confined, crowded, and poorly ventilated conditions facilitate the rapid spread of infectious diseases. OBJECTIVE: The COVID-19 in Prison Study aims to examine the epidemiology of SARS-CoV-2 in prisons in England in order to inform public health policy and practice during the pandemic and recovery. The primary objective is to estimate the proportion of positive tests of SARS-CoV-2 infection among residents and staff within selected prisons. The secondary objectives include estimating the incidence rate of SARS-CoV-2 infection and examining how the proportion of positive tests and the incidence rate vary among individual, institutional, and system level factors. METHODS: Phase 1 comprises a repeated panel survey of prison residents and staff in a representative sample of 28 prisons across England. All residents and staff in the study prisons are eligible for inclusion. Participants will be tested for SARS-CoV-2 using a nasopharyngeal swab twice (6 weeks apart). Staff will also be tested for antibodies to SARS-CoV-2. Phase 2 focuses on SARS-CoV-2 infection in prisons with recognized COVID-19 outbreaks. Any prison in England will be eligible to participate if an outbreak is declared. In 3 outbreak prisons, all participating staff and residents will be tested for SARS-CoV-2 antigens at the following 3 timepoints: as soon as possible after the outbreak is declared (day 0), 7 days later (day 7), and at day 28. They will be swabbed twice (a nasal swab for lateral flow device testing and a nasopharyngeal swab for polymerase chain reaction testing). Testing will be done by external contractors. Data will also be collected on individual, prison level, and community factors. Data will be stored and handled at the University of Southampton and Public Health England. Summary statistics will summarize the prison and participant characteristics. For the primary objective, simple proportions of individuals testing positive for SARS-CoV-2 and incidence rates will be calculated. Linear regression will examine the individual, institutional, system, and community factors associated with SARS-CoV-2 infection within prisons. RESULTS: The UK Government's Department for Health and Social Care funds the study. Data collection started on July 20, 2020, and will end on May 31, 2021. As of May 2021, we had enrolled 4192 staff members and 6496 imprisoned people in the study. Data analysis has started, and we expect to publish the initial findings in summer/autumn 2021. The main ethical consideration is the inclusion of prisoners, who are vulnerable participants. CONCLUSIONS: This study will provide unique data to inform the public health management of SARS-CoV-2 in prisons. Its findings will be of relevance to health policy makers and practitioners working in prisons. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30749.

Are socioeconomic inequalities in the incidence of small-for-gestational-age birth narrowing? Findings from a population-based cohort in the South of England.

OBJECTIVES: To investigate socioeconomic inequalities, using maternal educational attainment, maternal and partner employment status, and lone motherhood indicators, in the risk of small-for-gestational-age (SGA) births, their time trend, potential mediation by maternal smoking and body mass index, and effect modification by parity. DESIGN: Population-based birth cohort using routine antenatal healthcare data. SETTING: Babies born at University Hospital Southampton, UK, between 2004 and 2016. PARTICIPANTS: 65 909 singleton live births born to mothers aged ≥18 years between 24-week and 42-week gestation. MAIN OUTCOME MEASURES: SGA (birth weight <10th percentile for others born at the same number of completed weeks compared with 2013/2014 within England and Wales). RESULTS: Babies born to mothers educated up to secondary school level (adjusted OR (aOR) 1.32, 99% CI 1.19 to 1.47), who were unemployed (aOR 1.27, 99% CI 1.16 to 1.38) or with unemployed partners (aOR 1.27, 99% CI 1.13 to 1.43), were at greater risk of being SGA. There was no statistically significant change in the magnitude of this risk difference by these indicators over time between 2004 and 2016, as estimated by linear interactions with year of birth. Babies born to lone mothers were not at higher risk compared with partnered mothers after adjusting for maternal smoking (aOR 1.05, 99% CI 0.93 to 1.20). The inverse association between maternal educational attainment and SGA risk appeared greater in multiparous (aOR 1.40, 99% CI 1.10 to 1.77) compared with primiparous women (aOR 1.28, 99% CI 1.12 to 1.47), and the reverse was true for maternal and partner's unemployment where the association was stronger in primiparous women. CONCLUSIONS: Socioeconomic inequalities in SGA risk by educational attainment and employment status are not narrowing over time, with differences in association strength by parity. The greater SGA risk in lone mothers was potentially explained by maternal smoking. Preventive interventions should target socially disadvantaged women, including preconception and postpartum smoking cessation to reduce SGA risk.

Recurrent child mortality risks and parity transition in Nigeria.

BACKGROUND: Fertility rates remain persistently high in Nigeria, with little difference across socioeconomic groups. While the desire for large family size is culturally rooted, there is little understanding of how repeated child mortality experiences influence fertility behaviour and parity transition in Nigeria. METHODS: Using birth history data from the 2013 Nigeria Demographic and Health Survey (NDHS), we applied life table techniques and proportional-hazard regression model to explore the effect of child survival experience on parity transitions. We hypothesize that a woman with one or more child death experience is at elevated risk of progressing towards higher parities. RESULTS: Our findings show that child mortality is concentrated among mothers living in deprived conditions especially in rural areas of the northern part of Nigeria and among those with little or no education and, among those belonging to Hausa/Fulani ethnicity and Islam religion. Mothers with repeated experience of child deaths were significantly at a higher rate of progressing to higher parities than their counterparts (HR: 1.45; 95% CI: 1.31-1.61), when adjusted for relevant biological and socio-demographic characteristics. CONCLUSION: Recurrent experience of child deaths exacerbates the risks to higher parity transition. Interventions aimed at reducing fertility in Nigeria should target promoting child survival and family planning concurrently.

No effect of test and treat on sexual behaviours at population level in rural South Africa.

CONTEXT: Within the community-randomized ANRS 12249 Treatment-as-Prevention trial conducted in rural South Africa, we analysed sexual behaviours stratified by sex over time, comparing immediate antiretroviral therapy irrespective of CD4+ cell count vs. CD4+-guided antiretroviral therapy (start at CD4+ cell count > 350 cells/µl then >500 cells/µl) arms. METHODS: As part of the 6-monthly home-based trial rounds, a sexual behaviour individual questionnaire was administered to all residents at least 16 years. We considered seven indicators: sexual intercourse in the past month; at least one regular sexual partner in the past 6 months; at least one casual sexual partner in the past 6 months and more than one sexual partner in the past 6 months; condom use at last sex (CLS) with regular partner, CLS with casual partner, and point prevalence estimate of concurrency. We conducted repeated cross-sectional analyses, stratified by sex. Generalized Estimating Equations models were used, including trial arm, trial time, calendar time and interaction between trial arm and trial time. RESULTS: CLS with regular partner varied between 29-51% and 23-46% for men and women, respectively, with significantly lower odds among women in the control vs. intervention arm by trial end (P < 0.001). CLS with casual partner among men showed a significant interaction between arm and trial round, with no consistent pattern. Women declared more than one partner in the past 6 months in less than 1% of individual questionnaires; among men, rates varied between 5-12%, and odds significantly and continuously declined between calendar rounds 1 and 7 [odds ratio = 4.2 (3.24-5.45)]. CONCLUSION: Universal Test and Treat was not associated with increased sexual risk behaviours.

Community perceptions of the socio-economic structural context influencing HIV and TB risk, prevention and treatment in a high prevalence area in the era of antiretroviral therapy.

Following calls for targeted HIV prevention interventions in so-called "hotspots", we explored subjective perceptions of community members in places considered to be high HIV and tuberculosis (TB) transmission areas and those with low prevalence. Although more people now have access to antiretroviral therapy (ART), some areas are still experiencing high HIV transmission rates, presenting a barrier to the elimination of HIV. A rapid qualitative assessment approach was used to access a sample of 230 people who contributed narratives of their experiences and perceptions of transmission, treatment and prevention of HIV and TB in their communities. Theoretical propositions case study strategy was used to inform and guide the thematic analysis of the data with Research Department of Epidemiology & Public Health, University College London, London, UK. Our results support the concept of linking perceived control to health through the identification of structural factors that increase communities' sense of agency. People in these communities did not feel they had the efficacy to effect change in their milieu. The few socio-economic opportunities promote social mobility in search of better prospects which may have a negative impact on community cohesion and prevention strategies. Communities were more concerned with improving their immediate social and economic situations and prioritised this above the prevention messages. Therefore approaches that focus on changing the structural and environmental barriers to prevention may increase people's perceived control. Multifaceted strategies that address the identified constructs of perceived control may influence the social change necessary to make structural interventions successful.

Prevalence of sexually transmitted infections and bacterial vaginosis among women in sub-Saharan Africa: An individual participant data meta-analysis of 18 HIV prevention studies.

BACKGROUND: Estimates of sexually transmitted infection (STI) prevalence are essential for efforts to prevent and control STIs. Few large STI prevalence studies exist, especially for low- and middle-income countries (LMICs). Our primary objective was to estimate the prevalence of chlamydia, gonorrhea, trichomoniasis, syphilis, herpes simplex virus type 2 (HSV-2), and bacterial vaginosis (BV) among women in sub-Saharan Africa by age, region, and population type. METHODS AND FINDINGS: We analyzed individual-level data from 18 HIV prevention studies (cohort studies and randomized controlled trials; conducted during 1993-2011), representing >37,000 women, that tested participants for ≥1 selected STIs or BV at baseline. We used a 2-stage meta-analysis to combine data. After calculating the proportion of participants with each infection and standard error by study, we used a random-effects model to obtain a summary mean prevalence of each infection and 95% confidence interval (CI) across ages, regions, and population types. Despite substantial study heterogeneity for some STIs/populations, several patterns emerged. Across the three primary region/population groups (South Africa community-based, Southern/Eastern Africa community-based, and Eastern Africa higher-risk), prevalence was higher among 15-24-year-old than 25-49-year-old women for all STIs except HSV-2. In general, higher-risk populations had greater prevalence of gonorrhea and syphilis than clinic/community-based populations. For chlamydia, prevalence among 15-24-year-olds was 10.3% (95% CI: 7.4%, 14.1%; I2 = 75.7%) among women specifically recruited from higher-risk settings for HIV in Eastern Africa and was 15.1% (95% CI: 12.7%, 17.8%; I2 = 82.3%) in South African clinic/community-based populations. Among clinic/community-based populations, prevalence was generally greater in South Africa than in Southern/Eastern Africa for most STIs; for gonorrhea, prevalence among 15-24-year-olds was 4.6% (95% CI: 3.3%, 6.4%; I2 = 82.8%) in South Africa and was 1.7% (95% CI: 1.2%, 2.6%; I2 = 55.2%) in Southern/Eastern Africa. Across the three primary region/population groups, HSV-2 and BV prevalence was high among 25-49-year-olds (ranging from 70% to 83% and 33% to 44%, respectively). The main study limitation is that the data are not from random samples of the target populations. CONCLUSIONS: Combining data from 18 HIV prevention studies, our findings highlight important features of STI/BV epidemiology among sub-Saharan African women. This methodology can be used where routine STI surveillance is limited and offers a new approach to obtaining critical information on STI and BV prevalence in LMICs.

Impact of men's perception on family planning demand and uptake in Nigeria.

OBJECTIVE: Evidence from the last three Demographic and Health Surveys (DHS) in Nigeria shows slow progress in family planning (FP) uptake, despite programmatic interventions. While socioeconomic and religious barriers continue to exist, psychosocial factors such as negative contraceptive perceptions by male partners may influence both spousal FP demand and use. Therefore, this research investigates the influence of male partners' contraceptive perceptions on spousal FP demand and use. METHODS: We analysed the couple dataset from the 2013 Nigeria DHS. RESULTS: One in five men held the perception that contraceptive use is women's business whereas two in five men reported that women who use family planning may become promiscuous, especially older men, those with no formal education, Muslims and residents in rural areas and northern region. Results from regression models, controlling for relevant sociodemographic characteristics, show that men's perception that contraception is women's business did not significantly influence FP demand. However, their fear that women who use family planning may become promiscuous was associated with lower odds of FP demand (AOR: 0.86; 95% CI: 0.76-0.97) and increased the odds of traditional methods use (AOR: 1.34; 95% CI: 1.01-1.79). CONCLUSION: The findings direct the need to adopt targeted approach focusing on couples, and reorient policy and program efforts for FP counselling and behavioural changes in men.

Pneumococcal conjugate vaccine implementation in middle-income countries.

BACKGROUND: Since 2000, the widespread adoption of pneumococcal conjugate vaccines (PCVs) has had a major impact in the prevention of pneumonia. Limited access to international financial support means some middle-income countries (MICs) are trailing in the widespread use of PCVs. We review the status of PCV implementation, and discuss any needs and gaps related to low levels of PCV implementation in MICs, with analysis of possible solutions to strengthen the PCV implementation process in MICs. MAIN BODY: We searched PubMed, PubMed Central, Ovid MEDLINE, and SCOPUS databases using search terms related to pneumococcal immunization, governmental health policy or programmes, and MICs. Two authors independently reviewed the full text of the references, which were assessed for eligibility using pre-defined inclusion and exclusion criteria. The search terms identified 1,165 articles and the full texts of 21 were assessed for suitability, with eight articles included in the systematic review. MICs are implementing PCVs at a slower rate than donor-funded low-income countries and wealthier developed countries. A significant difference in the uptake of PCV in lower middle-income countries (LMICs) (71%) and upper middle-income countries (UMICs) (48%) is largely due to an unsuccessful process of "graduation" of MICs from GAVI assistance, an issue that arises as countries cross the income eligibility threshold and are no longer eligible to receive the same levels of financial assistance. A lack of country-specific data on disease burden, a lack of local expertise in economic evaluation, and the cost of PCV were identified as the leading causes of the slow uptake of PCVs in MICs. Potential solutions mentioned in the reviewed papers include the use of vaccine cost-effectiveness analysis and the provision of economic evidence to strengthen decision-making, the evaluation of the burden of disease, and post-introduction surveillance to monitor vaccine impact. CONCLUSION: The global community needs to recognise the impediments to vaccine introduction into MICs. Improving PCV access could help decrease the incidence of pneumonia and reduce the selection pressure for pneumococcal antimicrobial resistance.

Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation.

OBJECTIVE: To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. SETTING: We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. PARTICIPANTS: The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. OUTCOME MEASURE: The primary outcome measure was reliability and validity of the questionnaire. RESULTS: Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. CONCLUSIONS: We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants.

Chronic diseases and multi-morbidity--a conceptual modification to the WHO ICCC model for countries in health transition.

BACKGROUND: The burden of non-communicable diseases is rising, particularly in low and middle-income countries undergoing rapid epidemiological transition. In sub-Saharan Africa, this is occurring against a background of infectious chronic disease epidemics, particularly HIV and tuberculosis. Consequently, multi-morbidity, the co-existence of more than one chronic condition in one person, is increasing; in particular multimorbidity due to comorbid non-communicable and infectious chronic diseases (CNCICD). Such complex multimorbidity is a major challenge to existing models of healthcare delivery and there is a need to ensure integrated care across disease pathways and across primary and secondary care. DISCUSSION: The Innovative Care for Chronic Conditions (ICCC) Framework developed by the World Health Organization provides a health systems roadmap to meet the increasing needs of chronic disease care. This framework incorporates community, patient, healthcare and policy environment perspectives, and forms the cornerstone of South Africa's primary health care re-engineering and strategic plan for chronic disease management integration. However, it does not significantly incorporate complexity associated with multimorbidity and CNCICD.Using South Africa as a case study for a country in transition, we identify gaps in the ICCC framework at the micro-, meso-, and macro-levels. We apply the lens of CNCICD and propose modification of the ICCC and the South African Integrated Chronic Disease Management plan. Our framework incorporates the increased complexity of treating CNCICD patients, and highlights the importance of biomedicine (biological interaction). We highlight the patient perspective using a patient experience model that proposes that treatment adherence, healthcare utilization, and health outcomes are influenced by the relationship between the workload that is delegated to patients by healthcare providers, and patients' capacity to meet the demands of this workload. We link these issues to provider perspectives that interact with healthcare delivery and utilization. SUMMARY: Our proposed modification to the ICCC Framework makes clear that healthcare systems must work to make sense of the complex collision between biological phenomena, clinical interpretation, beliefs and behaviours that follow from these. We emphasize the integration of these issues with the socio-economic environment to address issues of complexity, access and equity in the integrated management of chronic diseases previously considered in isolation.

Sexual behaviour in a rural high HIV prevalence South African community: time trends in the antiretroviral treatment era.

OBJECTIVES: Data from generalized epidemic settings have consistently found that patients on antiretroviral therapy (ART) reduce sexual risk behaviours, but how sexual behaviour changes in the general population in response to ART availability, including amongst HIV-uninfected and undiagnosed adults, has not been characterized in these settings. DESIGN: General population open cohort. METHODS: We report trends in sexual behaviour indicators for men aged 17-54 years and women aged 17-49 years in rural KwaZulu-Natal province, based on annual sexual behaviour surveys during ART scale-up from 2005 to 2011. Estimates are adjusted for survey nonparticipation and nonresponse to individual survey items using inverse probability weighting and multiple imputation. Trends are presented by HIV status, knowledge of status, age and marital status. RESULTS: Reports of condom use at last sex with a regular partner increased by 2.6% points per year [95% confidence interval (CI) 1.5%, 3.7%] for men and 4.1% per year (3.0%, 5.3%) for women. Condom use at last sex with a casual partner was high and did not change significantly over the period for both sexes. There were statistically significant declines in the percentage reporting multiple partnerships in the last year and the point prevalence of concurrency. Trends within subgroups were generally consistent with overall estimates. CONCLUSION: We find no evidence of increased sexual risk-taking following ART availability and protective changes in some behaviours, suggesting that general trends in sexual behaviour are not counter-acting preventive effects of HIV treatment. Continued monitoring of population-level sexual behaviour indicators will be essential to interpret the success of combination-prevention programmes.

Mobile VCT: reaching men and young people in urban and rural South African pilot studies (NIMH Project Accept, HPTN 043).

Mounting evidence exists that mobile voluntary counselling and testing (VCT) is able to extend coverage to new localities and populations. We describe two feasibility and acceptability pilot studies conducted in rural and urban South Africa in preparation for the larger NIMH Project Accept HIV prevention trial. A total of 1,015 individuals participated in the pilot studies. Participants in rural Vulindlela were younger (median 22 years) compared to urban Soweto (p < 0.001). Young people were more likely to be first time testers in both sites (p = 0.01 in Vulindlela, p < 0.001 in Soweto), with significantly more men likely to be first time testers than women (p = 0.01 in Vulindlela, p < 0.001 in Soweto). User satisfaction with mobile VCT was extremely high in both sites. Our study shows that providing mobile, high-quality and easy to access services in a high prevalence context is a feasible way to engage youth, men and more rural populations in HIV counselling and testing.