Exploring linkages: addressing the relationship between the climate crisis and HIV prevention with recommendations for emerging pre-exposure prophylaxis programs.

Short- and long-term impacts of the climate crisis continue to be felt across the public health landscape. Many individuals marginalized by the climate crisis also navigate a higher likelihood of exposure to HIV. By understanding this relationship, we can better position HIV prevention, and pre-exposure prophylaxis (PrEP) programs specifically, to meet user needs in communities experiencing the effects of the climate crisis. In support, we propose four recommendations for mitigating the impact of the climate crisis on those who may benefit from PrEP: (1) leverage existing and emerging research and lived experience to intentionally target and appropriately reach individuals affected by the climate crisis who may need or want PrEP; (2) emphasize the need for more climate-resilient PrEP products within the research and development pipeline; (3) build a continued understanding of the role of the climate crisis-HIV relationship in product introduction through national collaboration; and (4) strengthen the integration of PrEP service delivery and response to intimate partner violence. The PrEP market is set for rapid expansion with the introduction of new prevention methods to enable choice. To be comprehensively responsive to potential PrEP users, we must consider and address how the climate crisis changes not only the environmental landscape, but the prevention ecosystem.

Increasing multimonth dispensing of antiretrovirals and assessing the effect on viral load suppression among children and adolescents receiving HIV services in Nigeria.

INTRODUCTION: Multimonth dispensing (MMD) enables less frequent clinic visits and improved outcomes for people living with HIV, but few children and adolescents living with HIV (CALHIV) are on MMD. At the end of the October-December 2019 quarter, only 23% of CALHIV receiving antiretroviral therapy (ART) through SIDHAS project sites in Akwa Ibom and Cross River states, Nigeria, were receiving MMD. In March 2020, during COVID-19, the government expanded MMD eligibility to include children and recommended rapid implementation to minimize clinic visits. SIDHAS provided technical assistance to 36 "high-volume" facilities-≥5 CALHIV on treatment-in Akwa Ibom and Cross River to increase MMD and viral load suppression (VLS) among CALHIV, toward PEPFAR's 80% benchmark for people currently on ART. We present change in MMD, viral load (VL) testing coverage, VLS, optimized regimen coverage, and community-based ART group enrollment among CALHIV from the October-December 2019 quarter (baseline) to January-March 2021 (endline) based on retrospective analysis of routinely collected program data. MATERIALS AND METHODS: We compared MMD coverage (primary objective), and optimized regimen coverage, community-based ART group enrollment, VL testing coverage, and VLS (secondary objectives), among CALHIV 18 years and younger pre-/post-intervention (baseline/endline) at the 36 facilities. We excluded children younger than two years, who are not recommended for or routinely offered MMD. The extracted data included age, sex, ART regimen, months of ART dispensed at last refill, most recent VL test results, and community ART group enrollment. Data on MMD-three or more months of ARVs dispensed at one time-were disaggregated into three to five months (3-5-MMD) vs. six or more months (6-MMD). VLS was defined as ≤1,000 copies. We documented MMD coverage by site, optimized regimen, and VL testing and suppression. Using descriptive statistics, we summarized the characteristics of CALHIV on MMD and non-MMD, number of CALHIV on optimized regimens, and proportion enrolled in differentiated service delivery models and community-based ART refill groups. For the intervention, SIDHAS technical assistance was data driven: weekly data analysis/review, site-prioritization scoring, provider mentoring, line listing eligible CALHIV, pediatric regimen calculator, child-optimized regimen transitioning, and community ART models. RESULTS: The proportion of CALHIV ages 2-18 receiving MMD increased from 23% (620/2,647; baseline) to 88% (3,992/4,541; endline), while the proportion of sites reporting suboptimal MMD coverage among CALHIV (<80%) decreased (100% to 28%). In March 2021, 49% of CALHIV were receiving 3-5-MMD and 39% 6-MMD. In October-December 2019, 17%-28% of CALHIV were receiving MMD; by January-March 2021, 99% of those 15-18 years, 94% 10-14 years, 79% 5-9 years, and 71% 2-4 years were on MMD. VL testing coverage remained high (90%), while VLS increased (64% to 92%). The proportion on pediatric-optimized regimens increased (58% to 79%). CONCLUSIONS: MMD was feasible among CALHIV without compromising VLS. Expanded eligibility criteria, line listing eligible children, monitoring pediatric antiretroviral stock, and data use contributed to positive results. Future efforts should address low 6-MMD uptake related to stock limitations and synchronize antiretroviral refill pickup with VL sample collection.

The CHARISMA Randomized Controlled Trial: A Relationship-Focused Counseling Intervention Integrated Within Oral PrEP Delivery for HIV Prevention Among Women in Johannesburg, South Africa.

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.

HIV Testing Approaches to Optimize Prevention and Treatment for Key and Priority Populations in Malawi.

Background: Despite progress in improving antiretroviral therapy (ART) for people with HIV in Malawi, the burden of HIV infections and HIV treatment outcomes among key populations is suboptimal. Client-centered differentiated service delivery approaches may facilitate addressing HIV prevention and treatment needs of key populations in Malawi. Methods: De-identified program data routinely collected as part of the LINKAGES project-Malawi were assembled from October 2017 to September 2019. HIV case finding was compared across different testing modalities for each population. Poisson regression was used to estimate the association between testing modalities and ART initiation. Results: Of the 18 397 people included in analyses, 10 627 (58%) were female sex workers (FSWs), 2219 (12%) were men who have sex with men (MSM), and 4970 (27%) were clients of FSWs. HIV case finding varied by modality and population, with index testing and enhanced peer outreach demonstrating high yield despite reaching relatively few individuals. FSWs who tested positive through risk network referral testing were more likely to initiate ART within 30 days compared with those who tested positive through clinic-based testing (adjusted risk ratio [aRR], 1.50; 95% CI, 1.23-1.82). For MSM, index testing (aRR, 1.45; 95% CI, 1.06-2.00) and testing through a drop-in center (aRR, 1.82; 95% CI, 1.19-2.78) were associated with 30-day ART initiation. Conclusions: These data suggest that differentiated HIV testing and outreach approaches tailored to the needs of different key populations may facilitate improved ART initiation in Malawi. Achieving 0 new infections by 2030 suggests the need to adapt treatment strategies given individual and structural barriers to treatment for key populations with HIV in high-prevalence settings.

Integration of a Relationship-focused Counseling Intervention with Delivery of the Dapivirine Ring for HIV Prevention to Women in Johannesburg: Results of the CHARISMA Pilot Study.

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.

How Home Delivery of Antiretroviral Drugs Ensured Uninterrupted HIV Treatment During COVID-19: Experiences From Indonesia, Laos, Nepal, and Nigeria.

INTRODUCTION: Faced with the coronavirus disease (COVID-19) pandemic, governments worldwide instituted lockdowns to curtail virus spread. Health facility closures and travel restrictions disrupted access to antiretroviral (ARV) therapy for people living with HIV. This report describes how HIV programs in Indonesia, Laos, Nepal, and Nigeria supported treatment continuation by introducing home delivery of ARVs. METHODS: Staff supporting the programs provided accounts of when and how decisions were taken to support ARV home delivery. They captured programmatic information about home delivery implementation using an intervention documentation tool. The 4 country experiences revealed lessons learned about factors favoring successful expansion of ARV home delivery. RESULTS: Three of the countries relied on existing networks of community health workers for ARV delivery; the fourth country, Indonesia, relied on a private sector courier service. Across the 4 countries, between 19% and 51% of eligible clients were served by home delivery. The experiences showed that ARV home delivery is feasible and acceptable to health service providers, clients, and other stakeholders. Essential to success was rapid mobilization of stakeholders who led the design of the home delivery mechanisms and provided leadership support of the service innovations. Timely service adaptation was made possible by pre-existing differentiated models of care supportive of community-based ARV provision by outreach workers. Home delivery models prioritized protection of client confidentiality and prevention measures for COVID-19. Sustainability of the innovation depends on reinforcement of the commodity management infrastructure and investment in financing mechanisms. CONCLUSION: Home delivery of ARVs is a feasible client-centered approach to be included among the options for decentralized drug distribution. It serves as a measure for expanding access to care both when access to health services is disrupted and under routine circumstances.

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.

Integrating Oral PrEP Into Family Planning Services for Women in Sub-saharan Africa: Findings From a Multi-Country Landscape Analysis.

Integration of HIV and family planning (FP) services is a renewed focus area for national policymakers, donors, and implementers in sub-Saharan Africa as a result of high HIV incidence among general-population women, especially adolescent girls and young women (AGYW), and the perception that integrating HIV pre-exposure prophylaxis (PrEP) into FP services may be an effective way to provide comprehensive HIV and FP services to this population. We conducted a focused desk review to develop a PrEP-FP integration framework across five key categories: plans and policies, resource management, service delivery, PrEP use, and monitoring and reporting. The framework was refined via interviews with 30 stakeholders across seven countries at varying stages of oral PrEP rollout: Kenya, Lesotho, Malawi, South Africa, Uganda, Zambia, and Zimbabwe. After refining the framework, we developed a PrEP-FP integration matrix and assessed country-specific progress to identify common enablers of and barriers to PrEP-FP integration. None of the countries included in our analysis had made substantial progress toward integrated PrEP-FP service delivery. Although the countries made progress in one or two categories, integration was often impeded by lack of advancement in other areas. Our framework offers policymakers, program implementers, and health care providers a road map for strategically assessing and monitoring progress toward PrEP-FP integration in their contexts.

Health systems software factors and their effect on the integration of sexual and reproductive health and HIV services.

Despite a large and growing body of literature on sexual and reproductive health (SRH) and HIV integration, the drivers of integration of SRH and HIV services, from a health systems perspective, are not well understood. These drivers include complex so-called hardware (structural and resource) and software (values and norms, and human relations and interactions) factors. Two groups of software factors emerge as essential enablers of effective integration of SRH and HIV services that often interact with systems hardware: (1) leadership, management, and governance processes and (2) provider motivation, agency, and relationships. Evidence suggests the potential for software elements that are essential enablers to overcome some of the obstacles posed by the non-integration of health system hardware elements (eg, financing, guidelines, and commodity supplies). These enabling factors include flexible decision making, inclusive management, and support in motivating frontline staff who can work with agency as a team. Improved software, even within constrained hardware (especially in low-income and middle-income countries), can directly contribute to improved SRH and HIV service delivery.

Peer Recruitment Strategies for Female Sex Workers Not Engaged in HIV Prevention and Treatment Services in Côte d'Ivoire: Program Data Analysis.

BACKGROUND: In the context of the mostly generalized HIV epidemic in Côte d'Ivoire, key populations bear a higher burden of HIV than that borne by the general reproductive-aged population. Mathematical models have demonstrated the significant potential impact and cost-effectiveness of improving the coverage of HIV prevention and treatment services for key populations in Côte d'Ivoire. However, in 2019, coverage of these services remained limited by multiple intersecting stigmas affecting key populations, necessitating the study of innovative implementation strategies to better meet the needs of those most marginalized. Here, we leverage programmatic data to compare the effectiveness of the enhanced and traditional peer outreach approaches in reaching and providing community HIV testing to female sex workers not readily engaged in HIV prevention and treatment services in Côte d'Ivoire. OBJECTIVE: The aim of this study was to describe the characteristics of female sex workers reached by the LINKAGES project in Côte d'Ivoire with enhanced peer outreach and traditional peer outreach and to compare HIV-related outcomes between the women reached by both strategies. METHODS: Deidentified routine programmatic data collected as part of LINKAGES Côte d'Ivoire between October 2017 and April 2018 were used in these analyses. Demographic characteristics and HIV indicators including HIV testing history, HIV case-finding, linkage to HIV treatment, and treatment initiation were assessed using descriptive statistics. Differences in these indicators were compared by outreach strategy using Pearson chi-square tests. RESULTS: There were 9761 women reached with enhanced peer outreach and routine peer outreach included in these analyses. The overall case-finding rate in the sample was 7.8% (698/8851). Compared with women reached by routine outreach, those reached by enhanced peer outreach were more likely to have previously been tested for HIV (enhanced: 1695/2509, 67.6%; routine: 4302/7252, 60.0%; χ21=43.8; P=.001). The enhanced peer outreach approach was associated with a higher HIV case-finding rate (enhanced: 269/2507 10.7%; routine: 429/6344, 6.8%; χ21=32.3; P=.001), higher proportion of linkage to treatment (enhanced: 258/269, 95.9%; routine: 306/429, 71.3%; χ21=64.4; P=.001), and higher proportion of treatment initiation (enhanced: 212/269, 78.8%; routine: 315/429, 73.3%; χ21=2.6; P=.11). Women reached by both approaches were categorized as high risk for HIV-related behaviors such as condomless sex and number of sex acts in the previous week. CONCLUSIONS: These analyses suggest that the novel peer-referral strategy, the enhanced peer outreach approach, was effective in reaching female sex workeres in Côte d'Ivoire with demonstrated acquisition risks for HIV and who had not been effectively engaged by routine outreach approaches. Scaling up novel strategies such as enhanced peer outreach in the context of differentiated service models may be needed to optimize HIV prevention and treatment outcomes for key populations in Côte d'Ivoire.

Assessing an inclusive model to increase access to comprehensive gender-based violence response services and improve HIV outcomes in Puerto Plata, Dominican Republic.

Experiences of gender-based violence (GBV) are associated with increased vulnerability to HIV and difficulty accessing HIV services; at the same time, people living with HIV are at an increased risk of GBV. Key populations most affected by HIV - gay and other men who have sex with men, female sex workers and transgender women - also experience a disproportionate burden of GBV. In Puerto Plata, Dominican Republic, a local civil society organisation has led efforts to improve and integrate GBV and HIV services while making them welcoming to key population members and people living with HIV. According to interviews with service providers and service users and an analysis of service statistics, the intervention improved service quality and coordination, increased disclosures of violence and increased GBV response service uptake among the general population, key population members and people living with HIV. Findings also suggest that the intervention increased the uptake of HIV services, including HIV testing and post-exposure prophylaxis, and improved mental health among those receiving GBV response services. This case study of integrated GBV and HIV services describes a new model for simultaneously, synergistically and inclusively addressing two major epidemics negatively affecting health and well-being in affected communities today.

Generating CHARISMA: Development of an Intervention to Help Women Build Agency and Safety in Their Relationships While Using PrEP for HIV Prevention.

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.

A research utilisation framework for informing global health and development policies and programmes.

A shift in the culture and practice of health and development research is required to maximise the real-world use of evidence by non-academic or non-research-oriented audiences. Many frameworks have been developed to guide and measure the research utilisation process, yet none have been widely applied. Some frameworks are simplified to an unrealistic linear representation while others are rendered overly complex and unusable in an attempt to capture all aspects of the research utilisation process. Additionally, many research utilisation frameworks have focused on the policy development process or within a clinical setting, with less application of the translation process at the programme level. In response to this gap - and drawing from over a decade of experience implementing research utilisation strategies - we developed a simple, four-phase framework to guide global health and development efforts that seek to apply evidence to policies and programmes. We present a detailed description of each phase in our framework, with examples of its relevance and application illustrated through our own case study experiences in global health. We believe the utility of this framework extends beyond the health sector and is relevant for maximising use of evidence to achieve the Sustainable Development Goals.

Meeting the Reproductive Health Needs of Female Key Populations Affected by HIV in Low- and Middle-Income Countries: A Review of the Evidence.

Female sex workers and other women at high risk of acquiring HIV have the right to sexual and reproductive health, including the right to determine the number and timing of pregnancies. We conducted a literature review to examine the data that exist regarding the family planning and reproductive health needs of female key populations, the underlying determinants of these populations' vulnerability to poor reproductive health outcomes, and the obstacles they face in accessing high-quality reproductive health services. Findings indicate that female key populations experience high rates of unmet need for family planning and safer conception services, unintended pregnancies, sexual violence, and abortion, and that they practice inconsistent condom use. Restrictive policy environments, stigma and discrimination in health care settings, gender inequality, and economic marginalization restrict access to services and undermine the ability to safely achieve reproductive intentions. We offer recommendations for structural, health system, community, and individual-level interventions that can mitigate the effects of these barriers and improve reproductive health outcomes.

Evaluation of a male engagement intervention to transform gender norms and improve family planning and HIV service uptake in Kabale, Uganda.

Men's limited understanding of family planning (FP) and harmful cultural gender norms pose obstacles to women's FP use. Thirty-two model men called 'Emanzis' were recruited from the community in Kabale, Uganda to lead men from their peer group through a 10-session curriculum designed to transform gender norms and motivate men to engage in FP and HIV services. Cross-sectional surveys were conducted before (n = 1251) and after (n = 1122) implementation. The Gender Equitable Men (GEM) Scale was used to assess the effect on gender attitudes. The intervention achieved negligible changes in responses to GEM items. Improvements in some gender-influenced health-seeking behaviours and practices in men were noted, specifically in visiting health facilities, HIV testing, and condom use. For future application, the intervention should be adapted to require higher peer educator qualifications, longer intervention duration, and more frequent supervision. Practical guidance is needed on where to direct investments in gender-transformative approaches for maximum impact.

Optimizing HIV prevention for women: a review of evidence from microbicide studies and considerations for gender-sensitive microbicide introduction.

INTRODUCTION: Microbicides were conceptualized as a product that could give women increased agency over HIV prevention. However, gender-related norms and inequalities that place women and girls at risk of acquiring HIV are also likely to affect their ability to use microbicides. Understanding how gendered norms and inequalities may pose obstacles to women's microbicide use is important to inform product design, microbicide trial implementation and eventually microbicide and other antiretroviral-based prevention programmes. We reviewed published vaginal microbicide studies to identify gender-related factors that are likely to affect microbicide acceptability, access and adherence. We make recommendations on product design, trial implementation, positioning, marketing and delivery of microbicides in a way that takes into account the gender-related norms and inequalities identified in the review. METHODS: We conducted PubMed searches for microbicide studies published in journals between 2000 and 2013. Search terms included trial names (e.g. "MDP301"), microbicide product names (e.g. "BufferGel"), researchers' names (e.g. "van der Straten") and other relevant terms (e.g. "microbicide"). We included microbicide clinical trials; surrogate studies in which a vaginal gel, ring or diaphragm was used without an active ingredient; and hypothetical studies in which no product was used. Social and behavioural studies implemented in conjunction with clinical trials and surrogate studies were also included. Although we recognize the importance of rectal microbicides to women, we did not include studies of rectal microbicides, as most of them focused on men who have sex with men. Using a standardized review template, three reviewers read the articles and looked for gender-related findings in key domains (e.g. product acceptability, sexual pleasure, partner communication, microbicide access and adherence). RESULTS AND DISCUSSION: The gendered norms, roles and relations that will likely affect women's ability to access and use microbicides are related to two broad categories: norms regulating women's and men's sexuality and power dynamics within intimate relationships. Though norms about women's and men's sexuality vary among cultural contexts, women's sexual behaviour and pleasure are typically less socially acceptable and more restricted than men's. These norms drive the need for woman-initiated HIV prevention, but also have implications for microbicide acceptability and how they are likely to be used by women of different ages and relationship types. Women's limited power to negotiate the circumstances of their intimate relationships and sex lives will impact their ability to access and use microbicides. Men's role in women's effective microbicide use can range from opposition to non-interference to active support. CONCLUSIONS: Identifying an effective microbicide that women can use consistently is vital to the future of HIV prevention for women. Once such a microbicide is identified and licensed, positioning, marketing and delivering microbicides in a way that takes into account the gendered norms and inequalities we have identified would help maximize access and adherence. It also has the potential to improve communication about sexuality, strengthen relationships between women and men and increase women's agency over their bodies and their health.

Engaging male partners in women's microbicide use: evidence from clinical trials and implications for future research and microbicide introduction.

INTRODUCTION: Constructively engaging male partners in women-centred health programs such as family planning and prevention of mother-to-child HIV transmission has resulted in both improved health outcomes and stronger relationships. Concerted efforts to engage men in microbicide use could make it easier for women to access and use microbicides in the future. This paper synthesizes findings from studies that investigated men's role in their partners' microbicide use during clinical trials to inform recommendations for male engagement in women's microbicide use. METHODS: We conducted primary and secondary analyses of data from six qualitative studies implemented in conjunction with microbicide clinical trials in South Africa, Kenya, and Tanzania. The analyses included data from 535 interviews and 107 focus groups with trial participants, male partners, and community members to answer research questions on partner communication about microbicides, men's role in women's microbicide use, and potential strategies for engaging men in future microbicide introduction. We synthesized the findings across the studies and developed recommendations. RESULTS: The majority of women in steady partnerships wanted agreement from their partners to use microbicides. Women used various strategies to obtain their agreement, including using the product for a while before telling their partners, giving men information gradually, and continuing to bring up microbicides until resistant partners acquiesced. Among men who were aware their partners were participating in a trial and using microbicides, involvement ranged from opposition to agreement/non-interference to active support. Both men and women expressed a desire for men to have access to information about microbicides and to be able to talk with a healthcare provider about microbicides. CONCLUSIONS: We recommend counselling women on whether and how to involve their partners including strategies for gaining partner approval; providing couples' counselling on microbicides so men have the opportunity to talk with providers; and targeting men with community education and mass media to increase their awareness and acceptance of microbicides. These strategies should be tested in microbicide trials, open-label studies, and demonstration projects to identify effective male engagement approaches to include in eventual microbicide introduction. Efforts to engage men must take care not to diminish women's agency to decide whether to use the product and inform their partners.