Examining Associations Between Mental Health, IPV Exposure, HIV Risk Behaviors, and PrEP Use in South African Women: An Analysis of Data from the Charisma Study.

Intimate partner violence (IPV) has been associated with poorer mental health outcomes and increased human immunodeficiency virus (HIV) risk behaviors. We examine the relations between IPV, mental health symptomology (defined as psychological distress and alcohol misuse), and engagement in HIV risk behaviors among a sample of South African women who participated in a randomized controlled trial of CHARISMA, an intervention to increase women's agency to use oral pre-exposure prophylaxis (PrEP) safely and consistently as well as mitigate relationship challenges. We also examined the impact of trial participation on women's mental health, as well as the impact of psychological distress on the effectiveness of the CHARISMA intervention. Mental health symptomology and IPV exposure were prevalent and associated with some HIV risk and protective behaviors. Trial participation reduced psychological distress. There was no evidence for mental health symptomology impacting the effectiveness of the CHARISMA intervention.

Changes in relationships, HIV risk, and feelings towards PrEP: findings from a qualitative explanatory study among participants in the CHARISMA intervention trial.

BACKGROUND: Intimate partner violence (IPV) and other relationship-based challenges have been demonstrated to reduce women's ability to use pre-exposure prophylaxis (PrEP) effectively for HIV prevention. The Community Health Clinical Model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) intervention was designed to mitigate these challenges and increase South African women's agency to use PrEP. The CHARISMA randomized controlled trial did not identify statistically significant differences in PrEP adherence or relationship dynamics between the intervention and control arms. As such, the aim of this explanatory qualitative sub-study was to understand women's experiences with the CHARISMA trial and explore reasons for the null results. METHODS: Twelve CHARISMA trial participants were purposively selected to participate in serial in-depth interviews, which took place at the trial end and 3 months later. Participants represented individuals who had received each of the three counselling modules, 1) healthy communication counselling, 2) PrEP disclosure counselling, or 3) IPV counselling, as well as those in the control arm who received IPV standard-of-care counselling. RESULTS: A thematic case analysis revealed numerous positive relationship outcomes among intervention participants, including identifying and ending unhealthy relationships, gaining a sense of personal empowerment, and enacting more positive behaviors and HIV risk reduction strategies in subsequent relationships. These positive shifts were occasionally described as contributing to decisions to discontinue PrEP use, which may partly explain the limited impact of the intervention on PrEP adherence. CONCLUSIONS: Future investigations of counselling interventions addressing relationship-based barriers to PrEP use should account for changing risk dynamics and need for PrEP.

"The role of case management in HIV treatment adherence: HPTN 078".

Adherence to care and antiretroviral therapy is challenging, especially for people living with HIV (PLWH) with additional co-occurring risk factors. Case management interventions, including motivational interviewing (MI), show promise to improve HIV treatment adherence, but few studies have examined how such interventions are delivered to or experienced by PLWH who have been reengaged in care. We conducted qualitative interviews with six case managers and 110 PLWH exiting from a randomized study (HPTN 078) who received a MI-based case management intervention in addition to standard patient-navigation services, or standard services only. Our study provided greater insight into the main findings from HPTN 078, including an in-depth description of the multiple barriers to adherence faced by this largely "out-of-care" population, as well as a more nuanced understanding of the benefits and challenges of implementing MI. A blend of MI plus more intensive interventions may be needed for PLWH facing multiple structural barriers.

Exploring individual-level barriers to HIV medication adherence among men who have sex with men in the HIV Prevention Trials Network (HPTN 065) study.

African-American men who have sex with men (MSM) with HIV are more likely to have unsuppressed viral load than other racial/ethnic groups. HPTN 065 Study, completed in 2015, consisted of five interconnected study components conducted at clinics in Bronx, New York and Washington, D.C. Participants completed surveys with questions related to socio-demographic factors and individual-level HIV medication adherence barriers, such as forgetting doses or fear of taking medications in front of others. Descriptive analyses and ordinal logistic regression with robust standard errors were conducted. Fifty-seven per cent of participants (N = 359) were African-American (57.1%) and roughly 40% had no more than a high school education. Mean age was 48 years. Overall, MSM with viral load suppression identified fewer individual-level barriers to adherence (p < .01) and individuals with depressive symptoms identified a greater number of barriers to adherence (p < .01). Compared to African-Americans, white MSM had a lower likelihood of identifying barriers to adherence (p < .05). Findings suggest that individual-level barriers to HIV medication adherence are common among MSM, irrespective of time since diagnosis and viral suppression. Race-specific interventions which address intersectional stigma are needed to improve health outcomes among African-American MSM, who bear much of the burden of poor HIV outcomes in the United States.

Acceptability and feasibility of the CHARISMA counseling intervention to support women's use of pre-exposure prophylaxis: results of a pilot study.

BACKGROUND: Women may need or seek male partner approval to safely and consistently use oral antiretroviral pre-exposure prophylaxis (PrEP) or vaginal microbicides. We developed CHARISMA, a counseling intervention to support women's relationships and their ability to consistently use HIV prevention products. METHODS: In a pilot study with 95 female participants in Johannesburg, South Africa, lay counselors implemented CHARISMA, assessing participants' relationship(s) with their male partner(s) and barriers or facilitators to HIV prevention method use, and then providing tailored, interactive counseling. We conducted study participant surveys and clinic staff interviews to evaluate CHARISMA's feasibility and acceptability. RESULTS: The CHARISMA pilot study indicates that a two-session relationship counseling intervention with 6-month follow-up to support women's ability to safely and effectively use vaginal microbicides was generally acceptable and feasible. Most participants thought CHARISMA was relevant, helpful, and about the right length, and that it had a positive impact on their relationships with their partners and their product use. Staff estimated that the intervention took 1.5-2 h to implement at enrollment and 45 min to an hour for the month 1 visit. They thought that overall CHARISMA was generally feasible to implement. CONCLUSIONS: Findings from this study suggest several lessons learned that may be relevant to others developing interventions supporting women's use of oral PrEP or vaginal microbicides. The use of lay counselors instead of nurses to deliver counseling appeared to be successful, but the counselors experienced significant stress from hearing about participants' traumatic experiences and required emotional support to avoid burnout. Although staff and participants felt that having multiple intervention sessions over time was valuable, a similar level of intensity may not be feasible in other settings. Further research is needed to determine an intervention delivery mode and follow-up period that optimally balances participant needs and clinic resources. Male engagement was a challenge, as it has been in previous studies of vaginal microbicides. Alternative strategies to reach men that do not require them to come to the clinic or rely on their female partners may be more effective.

Examining stigma, social support, and gender differences in unsuppressed HIV viral load among participants in HPTN 065.

Successful navigation of the HIV care continuum is necessary to maintain viral suppression. We explored gender-stratified correlates of being virally unsuppressed in the Prevention for Positives (P4P) component of HPTN 065. The outcome of interest was unsuppressed viral load (> 40 copies/mL) among individuals already living with HIV. Correlates included medication adherence factors, social support and stigma. Logistic regression models were stratified by gender (N = 673). Men-specific correlates of being virally unsuppressed included opposite-sex partners, older age and HIV disclosure stigma. Women-specific correlates included time since diagnosis, and personal-level barriers to medication adherence. When more individuals knew about their HIV status, women had over twice the likelihood of being virally unsuppressed; no such association was seen among men. Additionally, higher levels of social support were not associated with viral suppression among women. Interventions should consider gender-specific approaches to engaging social support in de-stigmatization of HIV and promotion of medication adherence and subsequent viral suppression.

'Either You Float or You Drown:' The Role of Social Ties and Stigma in Lived Experiences of the HIV Care Continuum in HPTN 065.

HPTN 065 utilized financial incentives to promote viral suppression among HIV-positive participants. Exit interviews were conducted in a sub-study of participants in Washington, DC and Bronx, NY. The present analyses explored lived experiences of social ties and stigma as individuals navigated the HIV care continuum, including gender differences in lived experiences. Using viral load data and informed by stages-of-change theory, participants were categorized into "Low-Adherers (n = 13)", "Action (n = 29)" and "Maintenance (n = 31)" stages. Secondary analyses of qualitative data were informed by grounded theory, and instances of social ties and stigma discussed by participants were quantified with descriptive statistics. Participants (N = 73) were mostly male (64%), African American (58%), with yearly income under $10,000 (52%). Low-adherers identified fewer, and sometimes more combative social ties than those in other adherence stages. Maintainers identified supportive ties as motivation for medication adherence (68%) but relied less on them for motivation than individuals in other adherence stages. Low-adherers described current experiences of stigma related to being diagnosed with HIV more than other adherence stages (23%). Individuals in Action reported stigma related to disclosing their HIV status to others (52%), while individuals in Maintenance mostly stigmatized others engaging in "risky" behaviors (32%). Findings suggest that women may perceive greater HIV stigma than men, perceive less supportive social ties, and were the majority of Low-adherers. Gender-informed approaches can facilitate community de-stigmatization of HIV, as African American women may be at greater risk of negative HIV health outcomes.

Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV-Uninfected Individuals: HPTN 077.

Long-acting injectable PrEP could offer an alternative to daily oral PrEP, improve adherence and protection, if found acceptable, safe and effective. HPTN 077 evaluated injectable cabotegravir safety, tolerability and pharmacokinetics among HIV-uninfected males and females in sequentially-enrolled cohorts of two dosing strategies. We compared acceptability of product attributes, prevention preferences and future interest in injectable PrEP (FIIP) by region, sex-at-birth, arm and cohort and used multivariable analysis to identify FIIP determinants. Baseline injectable PrEP preferences were higher in non-U.S. sites and increased in both regions over time. In multivariable models, FIIP was most strongly associated with acceptability of product attributes, was higher in non-U.S. sites and more altruistic participants. Treatment arm and report of pain were not associated with FIIP. Injectable acceptability was highest in non-U.S. sites. Preferences for injectable versus other PrEP methods were higher among U.S. males than females, but higher among males and females in non-U.S. settings.

Depression and Sexual Trauma Among Adolescent Girls and Young Women in HIV-Prevention Research in Tanzania.

PURPOSE: Clinical trials are necessary to test HIV-prevention strategies among adolescent girls and young women in sub-Saharan Africa. Psychosocial risk factors that increase girls' and young women's vulnerability for HIV may also impact their experiences in clinical trials. A better understanding of psychosocial risks among girls and young women enrolled in HIV-prevention research is needed. This analysis explores depression and sexual trauma among adolescent girls and young women enrolled in a mock microbicide trial in Tanzania. METHODS: We collected cross-sectional data from 135 HIV-negative adolescent girls and young women between 15 and 21 in Dar es Salaam, Tanzania enrolled in a mock microbicide trial. Depression, sexual behavior, and sexual trauma were measured. Sexual trauma and demographic variables were entered into a multivariate binomial logistic regression model predicting depression. FINDINGS: Overall, 27% of participants had moderate-to-severe depression. The most commonly endorsed items were anhedonia (lack of interest/pleasure) and low mood, which were reported by 78% of participants. Thoughts of suicide or self-harm were endorsed by 17% of participants. Coerced/forced first sex was reported by 42% of participants. Participants reporting coerced/forced first sex had 3.16 times the likelihood of moderate-to-severe depression. CONCLUSIONS: Depression and coerced/forced sex were common among participants in an HIV-prevention mock clinical trial in Tanzania. When enrolling adolescent girls and young women in HIV-prevention trials in sub-Saharan Africa, our research suggests the need for a trauma-informed approach, referrals for trauma and depression, and interventions that address the impact of depression and trauma on HIV prevention, clinical trial adherence, and clinical outcomes.

Stakeholder acceptability of adolescent participation in clinical trials for biomedical HIV prevention products: considerations from Tanzania and India.

Researchers and advocates have increasingly called for adolescent participation in clinical trials for new HIV prevention products, particularly adolescent girls in areas most affected by the epidemic. However, recent trials have highlighted the challenges for young women and adolescents to be able to effectively use new products that require daily dosing. This analysis provides a highly relevant context for this challenging environment by examining community members acceptability of adolescent girls' participation in clinical trials for new HIV prevention products. We conducted 41 in-depth interviews in Dar es Salaam, Tanzania and Pune, India with 22 key informants (KIs). Cultural perspectives on adolescent sexuality varied between countries, with KIs in Tanzania more readily acknowledging adolescent girls' sexual activity than KIs in India. KIs in both countries felt strongly adolescents must be well-informed about research concepts prior to participation, and emphasis should be given to preventative misconception. Despite concern in both countries that the trials might be seen as encouraging sexual behavior, KIs in Tanzania overwhelmingly supported adolescent inclusion, whereas KIs in India were more cautious. Involving adolescent girls in clinical trials for new HIV prevention products is potentially acceptable, although meaningful community engagement will be necessary.

The Role of Financial Incentives Along the Antiretroviral Therapy Adherence Continuum: A Qualitative Sub-study of the HPTN 065 (TLC-Plus) Study.

The stages of change (SOC) theory suggests individuals adapt incrementally to behaviors like adherence, requiring different strategies over the behavior change continuum. Offering financial incentives (FIs) is one strategy to motivate adherence. This qualitative sub-study examined adherence barriers and the role of FIs to increase viral suppression (VS) among HIV Prevention Trials Network (HPTN) 065 study participants categorized into SOC-related adherence stages based on changes from baseline to follow-up viral load tests. Of 73 participants, most were in Maintenance stage (n = 31), defined as having achieved VS throughout HPTN 065, or in Action stage (n = 29), defined as moving from virally unsuppressed to suppressed in 50% or more of tests. Only 13 were Low Adherers, having achieved VS in fewer than 50% of tests. The latter group faced substantial social and structural adherence barriers. Participants in the Action stage made positive changes to adherence routines to achieve VS. Those in Maintenance were less incentivized by FIs, as they were already committed. Results from this sub-study suggest FI effectiveness may vary across the SOC continuum, with greatest impact for those initiating antiretroviral or without explicit adherence routines. FIs may be insufficient to overcome strong social or structural barriers, and unnecessary for those intrinsically committed to remaining adherent.

School-based interventions for improving contraceptive use in adolescents.

BACKGROUND: Young women, especially adolescents, often lack access to modern contraception. Reasons vary by geography and regional politics and culture. The projected 2015 birth rate in 'developing' regions was 56 per 1000 compared with 17 per 1000 for 'developed' regions. OBJECTIVES: To identify school-based interventions that improved contraceptive use among adolescents SEARCH METHODS: Until 6 June 2016, we searched for eligible trials in PubMed, CENTRAL, ERIC, Web of Science, POPLINE, ClinicalTrials.gov and ICTRP. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that assigned individuals or clusters. The majority of participants must have been 19 years old or younger.The educational strategy must have occurred primarily in a middle school or high school. The intervention had to emphasize one or more effective methods of contraception. Our primary outcomes were pregnancy and contraceptive use. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the searches. One author extracted and entered the data into RevMan; a second author verified accuracy. We examined studies for methodological quality.For unadjusted dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For cluster randomized trials, we used adjusted measures, e.g. OR, risk ratio, or difference in proportions. For continuous outcomes, we used the adjusted mean difference (MD) or other measures from the models. We did not conduct meta-analysis due to varied interventions and outcome measures. MAIN RESULTS: The 11 trials included 10 cluster RCTs and an individually randomized trial. The cluster RCTs had sample sizes from 816 to 10,954; the median number of clusters was 24. Most trials were conducted in the USA and UK; one was from Mexico and one from South Africa.We focus here on the trials with moderate quality evidence and an intervention effect. Three addressed preventing pregnancy and HIV/STI through interactive sessions. One trial provided a multifaceted two-year program. Immediately after year one and 12 months after year two, the intervention group was more likely than the standard-curriculum group to report using effective contraception during last sex (reported adjusted ORs 1.62 ± standard error (SE) 0.22) and 1.76 ± SE 0.29), condom use during last sex (reported adjusted ORs 1.91 ± SE 0.27 and 1.68 ± SE 0.25), and less frequent sex without a condom in the past three months (reported ratios of adjusted means 0.50 ± SE 0.31 and 0.63 ± SE 0.23). Another trial compared multifaceted two-year programs on sexual risk reduction and risk avoidance (abstinence-focused) versus usual health education. At 3 months, the risk reduction group was less likely than the usual-education group to report no condom use at last intercourse (reported adjusted OR 0.67, 95% CI 0.47 to 0.96) and sex without a condom in the last three months (reported adjusted OR 0.59, 95% CI 0.36 to 0.95). At 3 and after 15 months, the risk avoidance group was also less likely than the usual-education group to report no condom use at last intercourse (reported adjusted ORs 0.70, 95% CI 0.52 to 0.93; and 0.61, 95% CI 0.45 to 0.85). At the same time points, the risk reduction group had a higher score than the usual-education group for condom knowledge. The third trial provided a peer-led program with eight interactive sessions. At 17 months, the intervention group was less likely than the teacher-led group to report oral contraceptive use during last sex (OR 0.57, 95% CI 0.36 to 0.91). This difference may not have been significant if the investigators had adjusted for the clustering. At 5 and 17 months, the peer-led group had a greater mean increase in knowledge of HIV and pregnancy prevention compared with the control group. An additional trial showed an effect on knowledge only. The group with an emergency contraception (EC) session was more likely than the group without the EC unit to know the time limits for using hormonal EC (pill) and the non-hormonal IUD as EC. AUTHORS' CONCLUSIONS: Since most trials addressed preventing STI/HIV and pregnancy, they emphasized condom use. However, several studies covered a range of contraceptive methods. The overall quality of evidence was low. Main reasons for downgrading the evidence were having limited information on intervention fidelity, analyzing a subsample rather than all those randomized, and having high losses.

Brief educational strategies for improving contraception use in young people.

BACKGROUND: Global high rates of unplanned pregnancy and abortion among young women demonstrate the need for increased access to modern contraceptive services. In sub-Saharan Africa, the birth rate for those aged 15 to 19 years is 121 per 1000. In the USA, 6% of teens aged 15 to 19 years became pregnant in 2010. Most pregnancies among young women to age 25 are unintended. OBJECTIVES: The aim was to identify brief educational interventions for improving contraceptive use among young people that are feasible for implementing in a clinic or similar setting with limited resources. SEARCH METHODS: To 7 March 2016, we searched for studies in CENTRAL, PubMed, POPLINE, Web of Science, ClinicalTrials.gov and ICTRP. SELECTION CRITERIA: We considered randomized controlled trials (RCTs) that assigned individuals or clusters as well as non-randomized studies (NRS). We included young people to age 25.The intervention had to be sufficiently brief for a clinic, i.e. one to three sessions of 15 to 60 minutes plus potential follow-up. The strategy had to emphasize one or more effective methods of contraception. Primary outcomes were pregnancy and contraceptive use. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the searches. One author extracted and entered the data into Review Manager; a second author verified accuracy. We examined studies for methodological quality.For dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). For continuous variables, we computed the mean difference (MD) with 95% CI. We used adjusted measures for cluster RCTs, typically ORs, that the investigators reported. For NRS, which need to control for confounding, we also used reported adjusted measures. We did not conduct meta-analysis due to varied interventions and outcome measures. MAIN RESULTS: We found 11 studies, published from 1983 to 2015, that included a total of 8338 participants. Ten were from the USA and one was from China. We focused here on intervention effects for our primary outcomes. Five studies showed some effect on contraceptive use. Of three RCTs that examined innovative counseling, one showed an intervention effect. At one year, adolescents with developmental counseling were more likely to use contraception effectively than those with standard counseling (OR 48.38, 95% CI 5.96 to 392.63).Three studies used an audiovisual tool plus counseling; two reported some effect on contraceptive use. An NRS with young men, aged 15 to 18, examined a slide-tape presentation plus reproductive health consultation. At one year, the intervention group was more likely than the standard-care group to report using an effective contraceptive and having a partner who used oral contraceptives (OCs), both at last intercourse (reported adjusted OR 1.51 and 1.66, respectively). Another study utilized a computer program for contraceptive decision-making plus standard counseling for women to age 20. At one year, fewer women in the intervention group at one site had not used OCs compared with the counseling-only group (3.4% versus 8.8%; reported P = 0.05).Three RCTs provided phone follow-up after counseling, one of which showed an effect on contraceptive use among women age 16 to 24. Women who received counseling plus phone calls to encourage contraceptive use were more likely than the counseling-only group to report consistent OC use at three months (OR 1.41, 95% CI 1.06 to 1.87) and six months (OR 1.39, 95% CI 1.03 to 1.87). Also at three months, they were more likely to report condom use at last sex (OR 1.45, 95% CI 1.03 to 2.03).Two cluster randomized trials trained providers on contraceptive methods and counseling. One trial with an intervention effect tested comprehensive contraceptive services for women to age 25, postabortion. At six months, the comprehensive-service group was more likely than the standard-care group to use an effective contraceptive (reported adjusted OR 2.03, 95% CI 1.04 to 3.98) and to use condoms consistently and correctly (reported adjusted OR 5.68, 95% CI 3.39 to 9.53). AUTHORS' CONCLUSIONS: Few studies tested brief strategies for young people. We noted heterogeneity across studies in participants' ages and life situations. Of five studies with some effect, one provided moderate-quality evidence; four were older studies with low-quality evidence. More intensive strategies could be more effective, but would also be challenging for many clinics to implement.

Theory-based interventions for contraception.

BACKGROUND: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, many educational interventions addressing contraception have no explicit theoretical base. OBJECTIVES: To review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice and encourage or improve contraceptive use. SEARCH METHODS: To 1 November 2016, we searched for trials that tested a theory-based intervention for improving contraceptive use in PubMed, CENTRAL, POPLINE, Web of Science, ClinicalTrials.gov, and ICTRP. For the initial review, we wrote to investigators to find other trials. SELECTION CRITERIA: Included trials tested a theory-based intervention for improving contraceptive use. Interventions addressed the use of one or more methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy and contraceptive choice or use. DATA COLLECTION AND ANALYSIS: We assessed titles and abstracts identified during the searches. One author extracted and entered the data into Review Manager; a second author verified accuracy. We examined studies for methodological quality.For unadjusted dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. We did not conduct meta-analysis due to varied interventions and outcome measures. MAIN RESULTS: We included 10 new trials for a total of 25. Five were conducted outside the USA. Fifteen randomly assigned individuals and 10 randomized clusters. This section focuses on nine trials with high or moderate quality evidence and an intervention effect. Five based on social cognitive theory addressed preventing adolescent pregnancy and were one to two years long. The comparison was usual care or education. Adolescent mothers with a home-based curriculum had fewer second births in two years (OR 0.41, 95% CI 0.17 to 1.00). Twelve months after a school-based curriculum, the intervention group was more likely to report using an effective contraceptive method (adjusted OR 1.76 ± standard error (SE) 0.29) and using condoms during last intercourse (adjusted OR 1.68 ± SE 0.25). In alternative schools, after five months the intervention group reported more condom use during last intercourse (reported adjusted OR 2.12, 95% CI 1.24 to 3.56). After a school-based risk-reduction program, at three months the intervention group was less likely to report no condom use at last intercourse (adjusted OR 0.67, 95% CI 0.47 to 0.96). The risk avoidance group (abstinence-focused) was less likely to do so at 15 months (OR 0.61, 95% CI 0.45 to 0.85). At 24 months after a case management and peer-leadership program, the intervention group reported more consistent use of hormonal contraceptives (adjusted relative risk (RR) 1.30, 95% CI 1.06 to 1.58), condoms (RR 1.57, 95% CI 1.28 to 1.94), and dual methods (RR 1.36, 95% CI 1.01 to 1.85).Four of the nine trials used motivational interviewing (MI). In three studies, the comparison group received handouts. The MI group more often reported effective contraception use at nine months (OR 2.04, 95% CI 1.47 to 2.83). In two studies, the MI group was less likely to report using ineffective contraception at three months (OR 0.31, 95% CI 0.12 to 0.77) and four months (OR 0.56, 95% CI 0.31 to 0.98), respectively. In the fourth trial, the MI group was more likely than a group with non-standard counseling to initiate long-acting reversible contraception (LARC) by one month (OR 3.99, 95% CI 1.36 to 11.68) and to report using LARC at three months (OR 3.38, 95% CI 1.06 to 10.71). AUTHORS' CONCLUSIONS: The overall quality of evidence was moderate. Trials based on social cognitive theory focused on adolescents and provided multiple sessions. Those using motivational interviewing had a wider age range but specific populations. Sites with low resources need effective interventions adapted for their settings and their typical clients. Reports could be clearer about how the theory was used to design and implement the intervention.

Preferences for oral and injectable PrEP among qualitative sub-study participants in HPTN 084.

BACKGROUND: HPTN 084 compared the safety and efficacy of long-acting injectable cabotegravir (CAB) to daily oral TDF/FTC for prevention of HIV-1 in uninfected African women. Like a similar trial in MSM/TGW (HPTN 083), the trial was stopped early for efficacy, expediting the need to consider introduction strategies for different populations. We examine survey and qualitative data from a four-country sub-study to examine oral and injectable PrEP acceptability and considerations for CAB access among African women. METHODS: Participants completed baseline and follow-up surveys on HIV risk perception, sexual behavior. product acceptability and adherence during the blinded trial. Additionally, up to two in-depth interviews each with 73 sub-study participants explored product use and trial-related experiences, during the blinded and unblinded study periods. Using survey data, we classified participants as: engaged in female sex work (FSW), having multiple non-transactional partners, or monogamous. A study statistician identified participants' assigned study arm. We followed a thematic analysis process to read transcripts, develop a codebook and apply codes in NVivo to transcripts with intermittent intercoder reliability checks; using Excel matrices to explore differences across risk categories and study arms. FINDINGS: Participants overwhelmingly preferred injections to pills, appreciating the ease, convenience, and privacy of a long-acting formulation. Many participants described challenges with contraceptive and/or study pill adherence, impeded by late night work, unexpected travel, or heavy drinking. Women in the TDF/FTC arm were more likely to describe side effects, compared to those in the CAB arm. Pain also varied widely by study arm. When considering post-trial access to CAB, limited PrEP knowledge, cost and concerns around stigma and poor service quality were potential access barriers. CONCLUSION: Women's desire for privacy and ease of use outweighed injectable concerns, resulting in a strong preference for CAB. Cost and accessibility will need to be addressed by implementation programs.

Theory-based interventions for contraception.

BACKGROUND: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, educational interventions addressing contraception often have no stated theoretical base. OBJECTIVES: Review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice; encourage contraceptive use; or promote adherence to, or continuation of, a contraceptive regimen. SEARCH METHODS: Through June 2013, we searched computerized databases for trials that tested a theory-based intervention for improving contraceptive use (MEDLINE, POPLINE, CENTRAL, PsycINFO, ClinicalTrials.gov, and ICTRP). Previous searches also included EMBASE. For the initial review, we wrote to investigators to find other trials. SELECTION CRITERIA: Trials tested a theory-based intervention for improving contraceptive use. We excluded trials focused on high-risk groups and preventing sexually transmitted infections or HIV. Interventions addressed the use of one or more contraceptive methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy, contraceptive choice or use, and contraceptive adherence or continuation. DATA COLLECTION AND ANALYSIS: The primary author evaluated abstracts for eligibility. Two authors extracted data from included studies. For the dichotomous outcomes, the Mantel-Haenszel odds ratio (OR) with 95% CI was calculated using a fixed-effect model. Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. No meta-analysis was conducted due to differences in interventions and outcome measures. MAIN RESULTS: We included three new trials for a total of 17. Ten randomly assigned individuals and seven were cluster-randomized. Eight trials showed some intervention effect.Two of 12 trials with pregnancy or birth data showed some effect. A theory-based group was less likely than the comparison group to have a second birth (OR 0.41; 95% CI 0.17 to 1.00) or to report a pregnancy (OR 0.24 (95% CI 0.10 to 0.56); OR 0.27 (95% CI 0.11 to 0.66)). The theoretical bases were social cognitive theory (SCT) and another social cognition model.Of 12 trials with data on contraceptive use (non-condom), six showed some effect. A theory-based group was more likely to consistently use oral contraceptives (OR 1.41; 95% CI 1.06 to 1.87), hormonal contraceptives (reported relative risk (RR) 1.30; 95% CI 1.06 to 1.58) or dual methods (reported RR 1.36; 95% CI 1.01 to 1.85); to use an effective contraceptive method (reported effect size 1.76; OR 2.04 (95% CI 1.47 to 2.83)) or use more habitual contraception (reported P < 0.05); and were less likely to use ineffective contraception (OR 0.56; 95% CI 0.31 to 0.98). Theories and models included the Health Belief Model (HBM), SCT, SCT plus another theory, other social cognition, and motivational interviewing (MI).For condom use, a theory-based group had favorable results in 5 of 11 trials. The main differences were reporting more consistent condom use (reported RR 1.57; 95% CI 1.28 to 1.94) and more condom use during last sex (reported results: risk ratio 1.47 (95% CI 1.12 to 1.93); effect size 1.68; OR 2.12 (95% CI 1.24 to 3.56); OR 1.45 (95% CI 1.03 to 2.03)). The theories were SCT, SCT plus another theory, and HBM.Nearly all trials provided multiple sessions or contacts. SCT provided the basis for seven trials focused on adolescents, of which five reported some effectiveness. Two others based on other social cognition models had favorable results with adolescents. Of six trials including adult women, five provided individual sessions. Some effect was seen in two using MI and one using the HBM. Two based on the Transtheoretical Model did not show any effect. AUTHORS' CONCLUSIONS: Eight trials provided evidence of high or moderate quality. Family planning researchers and practitioners could adapt the effective interventions, although most provided group sessions for adolescents. Three were conducted outside the USA. Clinics and low-resource settings need high-quality evidence on changing behavior. Thorough use of single theories would help in identifying what works, as would better reporting on research design and intervention implementation.

Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial.

Introduction: Most women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some point during their lifetime. While a range of contraceptive methods exist and options for HIV prevention are increasing, to date, only male and female condoms provide multipurpose protection from both pregnancy and disease. Methods: From September 2017 to December 2018, 60 women from the United States and the Dominican Republic, randomized 1:1 to continuous or interrupted use and 4:1 to active vs. placebo ring, participated in a Phase I trial to assess the safety and tolerability of a three-month multipurpose intravaginal ring (IVR) containing the antiviral tenofovir and the contraceptive levonorgestrel. This study examines survey responses from all participants and qualitative data from a subset of 17 women to assess acceptability of and preferences for IVR characteristics. Results: Overall, women liked the concept of a multipurpose IVR and found it easy to insert and remove. Initial concerns about the size or thickness of the ring generally disappeared with use experience. Women weighed trade-offs between the ease of continuous use for a longer duration against concerns about hygiene and discoloration of the ring when left in place during menses. Whether randomized to continuous or interrupted use, most women found ring attributes (size, thickness, flexibility) very acceptable. They provided recommendations via survey and qualitative interviews for ring modifications that would further increase acceptability. Insights into women's use experiences also suggest the need for clear counseling messages and introduction strategies that can facilitate women's choice and use of prevention methods. Discussion: Study findings suggest that a multipurpose IVR would make a valuable contribution to women's sexual and reproductive health options, and that both continuous and interrupted use strategies may be preferred.

Measuring Effects of Counseling to Increase Pre-Exposure Prophylaxis Adherence and Partner Support in South Africa Using the Healthy Relationship Assessment Tool.

INTRODUCTION: In response to the diverse roles and strong influence that male partners may have in women's decisions and ability to use HIV prevention products, we previously developed the counselor-administered Healthy Relationship Assessment Tool (HEART). This tool helps counselors tailor pre-exposure prophylaxis (PrEP) adherence support counseling to women's relationship dynamics with their sexual partners, suggesting modules for counselors to deliver. In this study, we examined the extent to which counselors used the HEART to guide the delivery of intervention modules and whether changes in subsequent HEART scores reflected the counseling module(s) received. METHODS: We conducted this study during a randomized controlled trial of the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) counseling intervention in Johannesburg, South Africa. Trained lay counselors administered the HEART to intervention group participants at enrollment (n=203) and at 3- and 6-month follow-up visits between October 2018 and April 2021. The HEART auto-calculated participants' response scores to recommend relevant counseling modules. We compared the mean scores for the 5 HEART scales across groups receiving different counseling modules. We also assessed changes in scale scores over time by the counseling module received. RESULTS: Although counselors could override HEART counseling module recommendations based on additional knowledge of participants' cases, they consistently agreed with the HEART recommendations. The HEART also triggered the sorting of women into counseling modules that they were positioned to successfully leverage. Additionally, participants' HEART scores changed over time in predictable ways based on the type of counseling module received. CONCLUSION: Overall, the tool performed as predicted and was consistent with past validation efforts of the HEART, indicating that the HEART may provide an efficient means to tailor women's counseling to address relationship-related challenges to PrEP adherence.

Intrauterine contraceptive discontinuation reasons among female trial participants living with HIV in Cape Town, South Africa: A qualitative analysis.

Introduction: While young women in South Africa may navigate both HIV infection and pregnancy risks, intrauterine contraceptive (IUC) use is low. Though IUCs have low failure rates, concerns exist about whether the IUC is an appropriate method choice for women living with HIV (WLHIV). In this qualitative study, we explore WLHIVs' experiences of using IUC and reasons for discontinuation. Methods: This qualitative study included in-depth interviews (IDIs) with 17 WLHIV who electively discontinued their allocated IUC while participating in a randomized controlled trial comparing the safety of the levonorgestrel intrauterine system (LNG-IUS) and the copper intrauterine device (C-IUD) in Cape Town, South Africa. The transcripts were coded and emergent themes were grouped to examine women's experiences with IUC use and reasons for discontinuation, highlighting experiential differences between the two methods. Results: Women's experience with the allocated IUC related most commonly to bleeding and/or abdominal pain just after insertion. Most C-IUD discontinuers, but only one LNG-IUS discontinuer, complained of pain and/or increased bleeding as the main reason for removal. Three women (two LNG-IUS, one C-IUD) requested removal because they desired pregnancy, while two others discontinued due to fears the IUC was exacerbating non-gynecologic conditions (hypertension, diabetes). Generally, women acknowledged advantages of IUC use and many expressed their desire to continue use if not for the side effects. Conclusions: In the South African context, IUC use for WLHIV should be promoted with specific counseling considerations. Both providers and potential users should receive specific information about potential menstrual-related side effects and countering common misperceptions to enable informed contraceptive decision-making.

Development of a relationship counselling website to identify and mitigate risk of intimate partner violence in the context of women's PrEP use.

Discreet, accessible interventions are urgently needed to mitigate the risk of intimate-partner violence (IPV) and other relationship barriers that women encounter to using HIV prevention methods such as pre-exposure prophylaxis (PrEP). We adapted a counsellor-administered intervention, CHARISMA, into a mobile-optimized website to enhance accessibility and reduce human resources required for HIV prevention and relationship counseling. Using human-centered design and participatory methods, CHARISMA was adapted through workshops with former CHARISMA in-person intervention participants (n = 14; ages 18-45) and web development 'sprints' combined with cognitive interviews (n = 24). 'CHARISMA mobile' was then beta-tested with 81 women naïve to the in-person intervention. In beta-testing, participants used a 'think aloud' process to provide feedback on ease of use and rated design, functionality, comprehension, confidentiality, safety, and usefulness on a scale of 1 to 5 via a survey. Data were conducted in four rounds, interspersed with rapid assessment according to go/no-go criteria, and website adaptations. The updated website was pilot tested for 'real-world' feasibility and acceptability among 159 women using their own smartphones at a location of their choice. Feedback was measured via surveys and website analytics. Workshops and cognitive interviews generated insights on technology use, contextual adaptations, and confidentiality, which were integrated into the beta version. The beta version met all 'go' criteria and was further adapted for pilot testing. In pilot testing, users found the website was useful (mean rating 4.54 out of 5), safe (4.5 out of 5), and had few concerns about confidentiality (1.75, representing low concern). On average, users rated the website more than 4 stars out of 5. Beta and pilot-testing suggested the smartphone-optimized website was well-accepted, relevant, engaging, feasible to administer, discreet and safe. Results contributed to a refined website, suitable for adaptations to other contexts and further evaluation where outcomes related to PrEP use and relationships should be assessed.