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Improving intimate partner violence interventions requires understanding pathways to change among couples participating in these interventions. This article presents qualitative data from 18 males and 16 females who participated in a combined behavioral economics (contingency management) and cognitive behavioral therapy alcohol and violence reduction intervention trial in Bengaluru, India. Results confirmed several theorized pathways of change, as well as identified further mechanisms through which the intervention supported the change. These included the emotional impacts of incentives, perceived and actual accountability via breathalyzers and family involvement, and enhanced support gained through counseling skills. Findings reveal critical insights into intervention design for future implementation., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Tu'Washindi intervention addressed intimate partner violence (IPV) and relationship dynamics to increase PrEP use among adolescent girls and young women (AGYW) in Siaya County, Kenya. We evaluated feasibility and acceptability in a cluster-randomized trial in six DREAMS Safe Spaces. The multilevel intervention, delivered over 6 months, included three components delivered by DREAMS staff with support from the study team: an 8-session structured support club; community sensitization of male partners; and a couples PrEP education and health fair ("Buddy Day"). Feasibility and acceptability assessments included implementation process measures, questionnaires, and focus group discussions with AGYWs and post-intervention questionnaires with intervention providers. The study included 103 AGYWs aged 17 to 24 (N = 49 intervention), with 97% retention. Median age was 22, 54% were married, and 84% were mothers. At enrollment, 45% used PrEP and 61% reported lifetime IPV. All intervention participants attended at least one support club session (mean = 5.2 of 8) and 90% attended Buddy Day. At 6 months, most participants perceived Tu'Washindi to be effective: all agreed (with 54% reporting "strongly agree") that the intervention improved partner communication and 60% agreed they were better able to gain partner support for their PrEP use. Providers believed the intervention resonated with community values. Tu'Washindi was highly acceptable and feasible and it was perceived by AGYW participants and providers as being effective in improving partner relationships and supporting PrEP use., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Oral pre-exposure prophylaxis (PrEP) has the potential to reduce HIV acquisition among adolescent girls and young women (AGYW) in sub-Saharan Africa, a priority population for epidemic control. However, intimate partner violence (IPV) and low relationship power can create significant challenges to PrEP use. The Tu'Washindi intervention aimed to increase PrEP use by addressing relationship- and violence-related barriers among AGYW enrolled in the DREAMS Initiative in Siaya County, Kenya., Methods: Our multi-level, community-based intervention was piloted in a cluster-randomized controlled trial conducted at six DREAMS sites from April to December 2019 (NCT03938818). Three intervention components were delivered over 6 months: an eight-session empowerment-based support club, community sensitization targeted towards male partners and a couples' PrEP education event. Participants were ages 17-24, HIV negative and either eligible for, or already taking, PrEP. Over 6 months of follow-up, we assessed IPV (months 3 and 6) and PrEP uptake and continuation (month 6) through interviewer-administered questionnaires; PrEP adherence was assessed with Wisepill electronic monitoring devices. These outcomes were compared using adjusted Poisson and negative binomial regression models., Results: We enrolled 103 AGYW with median age of 22 years (IQR 20-23); one-third were currently taking PrEP and 45% reported IPV in the past 3 months. Retention was 97% at month 6. Compared to the control arm, intervention arm participants were more likely to initiate PrEP, if not already using it at enrolment (52% vs. 24%, aRR 2.28, 95% CI 1.19-4.38, p = 0.01), and those taking PrEP had more days with device openings (25% of days vs. 13%, aRR 1.94, 95% CI 1.16-3.25, p = 0.01). Twenty percent of participants reported IPV during follow-up. There were trends towards fewer IPV events (aIRR 0.66, 95% CI 0.27-1.62, p = 0.37) and fewer events resulting in injury (aIRR 0.21, 95% CI 0.04-1.02, p = 0.05) in the intervention versus control arm., Conclusions: Tu'Washindi shows promise in promoting PrEP uptake and adherence among AGYW without concomitant increases in IPV; however, adherence was still suboptimal. Further research is needed to determine whether these gains translate to increases in the proportion of AGYW with protective levels of PrEP adherence and to evaluate the potential for the intervention to reduce IPV risk., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Growing evidence indicates that gender-based violence (GBV) increased during COVID-19. We investigated self-reported impact of the pandemic on GBV at community, household and intimate partner (IPV) levels among young people and its associations with psychosocial wellbeing, i.e., COVID-related stressors and mental health., Methods: Cross-sectional data were drawn from a survey with young people ages 13-24 (N = 536) living with HIV (YPLWH) and without HIV (YPLWoH), in peri-urban Cape Town, South Africa. The survey, conducted February-October 2021, examined the impact of the initial lockdown on experience and perceived changes in GBV at each level, and pandemic-related psychosocial wellbeing. Descriptive statistics and binomial and multinomial regression analyses were conducted to illustrate exposure and perceived changes in GBV since lockdown, and their association with COVID-related stress factors (e.g., social isolation, anxiety about COVID), mental health (e.g., depression, anxiety), and other risk factors (e.g., age, gender, socioeconomic status) by HIV status., Results: Participants were 70% women with mean age 19 years; 40% were living with HIV. Since lockdown, YPLWoH were significantly more likely than YPLWH to perceive community violence as increasing (45% vs. 28%, p < 0.001), and to report household violence (37% vs. 23%, p = 0.006) and perceive it as increasing (56% vs. 27%, p = 0.002) (ref: decreasing violence). YPLWoH were also more likely to report IPV experience (19% vs. 15%, p = 0.41) and perception of IPV increasing (15% vs. 8%, p = 0.92). In adjusted models, COVID-related stressors and common mental health disorders were only associated with household violence. However, indicators of economic status such as living in informal housing (RRR = 2.07; 95% CI = 1.12-3.83) and food insecurity (Community violence: RRR = 1.79; 95% CI = 1.00-3.20; Household violence: RRR = 1.72; 95% CI = 1.15-2.60) emerged as significant risk factors for exposure to increased GBV particularly among YPLWoH., Conclusions: Findings suggest that for young people in this setting, GBV at community and household levels was more prevalent during COVID-19 compared to IPV, especially for YPLWoH. While we found limited associations between COVID-related stressors and GBV, the perceived increases in GBV since lockdown in a setting where GBV is endemic, and the association of household violence with mental health, is a concern for future pandemic responses and should be longitudinally assessed., (© 2023. The Author(s).)

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., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Consistent use of oral pre-exposure prophylaxis (PrEP) has been a challenge among women, particularly when in relationships with lack of partner support or intimate partner violence (IPV)., Methods: We conducted a randomized controlled trial (RCT) of an empowerment counseling intervention called "CHARISMA" delivered to women within a PrEP demonstration project in Johannesburg, South Africa. The trial tested the effectiveness of CHARISMA to increase PrEP adherence; decrease social harms and IPV; and improve partnership dynamics (eg, communication, disclosure and support) compared with those who received the standard of care counselling support and referrals. Four hundred seven HIV-seronegative, nonpregnant women aged 18-45 years were enrolled for 6 months of PrEP use, with 203 randomized (1:1) to the intervention. All participants reporting IPV received counseling and referrals that followed the WHO five-step Listen, Inquire, Validate, Enhance Safety, and Support approach., Results: This RCT did not identify statistically significant differences between study arms for PrEP adherence or relationship dynamics, with the exception of an increase in PrEP disclosure among intervention arm women. In our study, we cannot determine whether the lack of detectable findings may have been because of lack of intervention effect, strength of standard of care services, low risk in the study population, or other factors., Conclusions: Addressing IPV and relationship dynamics remain important factors influencing HIV risk, and addressing these within the context of PrEP delivery is an important synergistic opportunity. CHARISMA was highly acceptable to participants, and further adaptation and testing of the intervention to other populations and settings will augment the evidence base., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Biomedical, female-initiated HIV prevention methods can help reduce disproportionately high HIV rates among women in sub-Saharan Africa, but male partner resistance and intimate partner violence (IPV) may impact ability to ensure effective use. To support consistent use of the dapivirine vaginal ring (VR), we pilot-tested the impact of the CHARISMA relationship counseling intervention ("CHARISMA") with women enrolled in the multi-site open-label Microbicide Trials Network (MTN) 025/HOPE trial at the Wits Reproductive Health and HIV Research Institute (Wits RHI) site in Johannesburg, South Africa. Lay counselors used a 42-item tool with five subscales to assess relationships and IPV and provide tailored counseling at enrolment, followed by a booster counselling session at Month 1 and follow-up checks at Months 3 and 6. We evaluated potential impact by examining self-reported ring disclosure to partners, partner clinic attendance, self-reported incident social harms (SH) and IPV, and biomarkers of ring adherence at Wits RHI. We subsequently compared these outcomes at three comparator HOPE study sites using multivariable regression models. Comparator study sites were purposively selected as those most similar to Wits RHI for baseline characteristics identified a priori. At Wits RHI, 95 of 96 (99%) HOPE participants enrolled into the CHARISMA pilot study. Mean age was 30, 36.8% lived with a partner, and 85.3% received their partner's financial support. During the six months of pilot study follow-up, participants reported: ring use disclosure to partners at 72.7% visits; 4.3% partners attending the research clinic; one partner-related SH; and 9.5% experienced incident IPV. The mean level of dapivirine released from returned used rings was 3.4 mg (SD 1.56), suggesting moderate adherence. Participants in the CHARISMA pilot had high background prevalence and incidence of IPV but were nevertheless able to adhere to ring use, and some male partners came to the research clinic. In adjusted regression models, compared to Wits RHI, partner clinic attendance was lower at all comparator sites; and significantly so at Site A (aRR 0.12, 95% CI 0.00-0.98). Sites B and C had lower levels of dapivirine released (suggesting lower adherence), but this difference was not significant. Site B women were more likely to report ring disclosure to partners at FU visits (aRR 1.12, 95% CI 1.00-1.25). IPV reported during follow-up was significantly lower at Site B (aRR 0.20, 95% CI 0.04-0.98, p = 0.047). CHARISMA taught women skills to decide on levels of ring-use disclosure to partners or others; therefore it is difficult to interpret differences in ring disclosure to partners with other sites. Similarly, CHARISMA heightened participants' awareness of abuse, possibly increasing IPV reports. Testing CHARISMA under fully-powered controlled conditions will improve understanding of its impact on women's relationships and ability to use female-initiated HIV prevention methods., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: The CHARISMA intervention, nested within the MTN-025/HOPE vaginal ring trial in Johannesburg, South Africa, seeks to facilitate women's use of HIV prevention products by promoting partner dialogue and mitigating intimate partner violence (IPV). We developed "HEART", a lay counselor-administered relationship assessment tool, for the CHARISMA pilot. The five-scale tool assesses participants' endorsement of Traditional Values (TV), her HIV Prevention Readiness (HPR) and levels of partner support (PS), abuse and control (PAC), and resistance to HIV prevention (PR), guiding decisions about which of three counselling modules to offer (partner communication/A; ring disclosure/B; and IPV prevention/C)., Methods: We correlated baseline scores on HEART subscales with a) independent measures of relationship stability, disclosure and IPV to assess construct validity, and b) with specific modules offered to determine how HEART was used in the pilot. We examined changes in HEART scores at three and six months. Finally, we ran separate growth models for each subscale to examine changes in scores, accounting for partnership changes and counseling module(s) received., Results: Baseline HEART scores correlated as predicted among subscales and with other measures. Reliabilities for four subscales were 0.75 or higher. Women who disclosed study participation and ring use scored higher on PS and lower on PR. Women experiencing IPV scored lower on PS, and higher on PAC and PR. During the pilot, 82% of women received one and 17% received two or more modules; over half received the IPV module. Women with higher PAC and PR scores were more likely to receive the IPV than the communication or disclosure modules. Over time, the TV, PAC and PR scores decreased, and PS score increased. Receiving the IPV module was associated with a decreased PAC score., Conclusions: These data offer preliminary evidence for HEART construct and predictive validity and support its further evaluation to guide implementation and monitor the impact of the CHARISMA intervention in a randomized controlled evaluation., Competing Interests: The authors have declared that no competing interests exist.

Hazardous drinking is an important contributing factor to intimate partner violence (IPV) occurrence. However, only a limited number of community-based alcohol reduction interventions have been tested in low- and middle-income countries (LMICs) for their efficacy in reducing IPV. This pilot intervention study tested a 1-month combined behavioral economics and cognitive behavioral therapy intervention to reduce hazardous alcohol use and IPV in Bengaluru, India. Sixty couples were randomized to one of three study arms to test the effect of incentives-only and incentives plus counseling interventions compared with a control condition. Alcohol use among male participants was assessed using breathalyzer tests. Violence experienced by female participants was measured using the Indian Family Violence and Control Scale. Couples in the counseling arm participated in four weekly counseling sessions. Male participants in the incentive arms earned a reward for sobriety (breath alcohol concentration [BrAC] <0.01 g/dl). Results showed that while incentives reduced alcohol use, there was a greater proportion of negative BrAC samples among participants in the counseling arm compared with the control group (0.96 vs. 0.76, p = .03). Violence also decreased in both intervention arms. The estimated mean violence score for the counseling arm was 10.8 points lower than the control arm at 4-month follow-up visit ( p = .02). This study contributes important evidence to the field of alcohol reduction and IPV prevention approaches in LMIC settings and adds to the growing evidence that alcohol reduction is a modifiable means of addressing IPV.

This article describes the development of the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence intervention (CHARISMA), an intervention designed to address the ways in which gender norms and power differentials within relationships affect women's ability to safely and consistently use HIV pre-exposure prophylaxis (PrEP). CHARISMA development involved three main activities: (1) a literature review to identify appropriate evidence-based relationship dynamic scales and interventions; (2) the analysis of primary and secondary data collected from completed PrEP studies, surveys and cognitive interviews with PrEP-experienced and naïve women, and in-depth interviews with former vaginal ring trial participants and male partners; and (3) the conduct of workshops to test and refine key intervention activities prior to pilot testing. These steps are described along with the final clinic and community-based intervention, which was tested for feasibility, acceptability, and preliminary effectiveness in Johannesburg, South Africa.

Despite being designed for autonomous use, research suggests partner approval is often in women's microbicide use. Microbicide study participants have described many ways product use affects relationships, from improving sexual pleasure to increasing harm, including exacerbating intimate partner violence (IPV). As the dapivirine ring proceeds closer to licensure, supporting women's agency to use microbicides safely is a priority. We conducted 42 in-depth interviews with former participants of the Microbicide Trials Network (MTN)-020 trial of the dapivirine vaginal ring and their male partners in Johannesburg, South Africa, to explore how ring use and partnership dynamics interacted. We sampled women who reported harms or partner non-support and women with supportive partners. Male and female narratives revealed high background levels of IPV. Women described how study participation/ring use exacerbated violence, and for a few couples served as a rationale for additional abuse. In response, women described feeling powerless and fearful of conflict, resulting in product nonuse. For one participant violence was reduced, and for several others, empowerment was sparked. These findings suggest future providers have the opportunity to shift more women from a place of fear/violence to one of safety/empowerment through the integration of IPV screening and relationship counselling.

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. [ABSTRACT FROM AUTHOR]

In HIV prevention trials, male partners have influenced women's ability to adhere to investigational products, including antiretroviral (ARV) containing vaginal rings. Validated scales can be useful tools to systematically measure complex constructs, such as those related to male partner engagement. Although multiple scales exist to assess physical, psychological and sexual violence within intimate relationships, fewer scales focus on supportive behaviors within these relationships. Our intervention involved development of a Healthy Relationship Assessment Tool (HEART) that assessed both positive and negative aspects of male partner involvement in women's HIV prevention. We identified and refined 127 potential items, representing intimate partner violence, agency and social support. A structured survey, including potential items and other sociodemographic and behavioral variables was administered to former microbicide trial and non-trial participants. We conducted an exploratory factor analysis (EFA) to identify a reduced set of constructs and items to screen women who might experience social harms or benefits from vaginal ring use. We examined associations between constructs and with other survey variables to assess content and construct validity. In a subset of 10 women who participated in the survey and qualitative interviews, we used qualitative data to predict survey scores. We retained five constructs with theoretical relevance and good-to-strong reliability for the tool, including: Traditional Values; Partner Support; Partner Abuse & Control; Partner Resistance to HIV Prevention; and HIV Prevention Readiness. Predicted associations between HEART constructs, and correspondence between participants' qualitative data and HEART scores were generally correct, while those between constructs and other sociodemographic variables were more mixed. Initial validation of the HEART tool was promising. The tool will be used during the CHARISMA pilot study at the Johannesburg MTN 025/HOPE site and validated as part of a randomized controlled trial of CHARISMA within a PrEP demonstration project. Beyond clinical trial settings, HEART could assist PrEP or antiretroviral treatment (ART) providers with an easy-to-administer tool to identify risk and tailor risk reduction, empowerment and adherence counseling for microbicides, PrEP or ART related services. [ABSTRACT FROM AUTHOR]