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.

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.

Engaging HIV-prevention ambassadors to promote oral PrEP among adolescent girls and young women: results of a Zimbabwe field test.

The HIV Prevention Ambassador Training Package for Adolescent Girls and Young Women was created in collaboration with adolescent girls and young women (AGYW) to improve skills, knowledge, and attitudes about oral pre-exposure prophylaxis (PrEP) among peer "ambassadors". It was field tested with 17 ambassadors in Mazowe District, Zimbabwe and changes in ambassadors' knowledge and attitudes about oral PrEP, as well as changes in oral PrEP uptake among AGYW in the district, were assessed. The training package improved oral PrEP knowledge among trained ambassadors and built AGYW's skills to advocate for oral PrEP awareness and rollout. Use of the training package correlated with a 59% increase in oral PrEP uptake among AGYW in Mazowe District in the seven months following the training. The ambassador training package could help support oral PrEP introduction and scale up in countries with high HIV incidence by engaging AGYW in oral PrEP rollout in their communities.

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.

Health care providers' attitudes toward and experiences delivering oral PrEP to adolescent girls and young women in Kenya, South Africa, and Zimbabwe.

BACKGROUND: In Kenya, South Africa, and Zimbabwe, oral pre-exposure prophylaxis (PrEP) is recommended for adolescent girls and young women (AGYW) at high risk of HIV. Health providers play a critical role in the uptake and effective use of sexual and reproductive health services; however, few published studies have explored providers' attitudes toward and experiences delivering PrEP to AGYW. METHODS: We conducted a cross-sectional qualitative study, interviewing 113 providers at 36 public, private, and nongovernmental health facilities in Kenya, South Africa, and Zimbabwe that were offering PrEP during the research period or were likely to offer PrEP in the future. Data were coded in NVivo 11, and an applied thematic analysis was conducted. RESULTS: Most providers preferred that adolescent girls wait until age 18 to have sex but acknowledged that many girls younger than 18 could benefit from oral PrEP. Their primary concern was whether adolescent girls would be able to take PrEP daily, especially if they do not tell their parents or partners they are using it. Providers reported that it was more challenging to deliver PrEP and other HIV services to girls younger than 18. Those with experience providing PrEP pointed to stigma and lack of PrEP awareness in communities as two primary barriers to PrEP uptake and use. CONCLUSIONS: Providers were generally accepting of oral PrEP as an HIV prevention option for AGYW; however, many had negative attitudes about adolescent girls being sexually active and concerns about whether they could take PrEP daily. Results were used to update national PrEP training materials to address negative provider attitudes about PrEP use by AGYW.

The health impacts of violence perpetrated by police, military and other public security forces on gay, bisexual and other men who have sex with men in El Salvador.

Gay, bisexual and other men who have sex with men face both high levels of violence and a disproportionate burden of poor health outcomes. We explored violence perpetrated against Salvadoran gay, bisexual and other men who have sex with men by public security forces; perceived motivations of violence; and impacts on health. We conducted structured qualitative interviews with 20 participants and used systematic coding and narrative analysis to identify emergent themes. Nearly all participants described the physical, emotional, sexual and/or economic violence by public security forces. Most attributed being targeted to their gender expression and/or perceived sexual orientation. The most common impact was emotional distress, including humiliation, fear and depression; lasting physical injuries were also widely reported. Study participants felt unable to report these incidents for fear of retribution or inaction. Men reported feelings of helplessness and distrust, avoidance of authorities and altering when, where or how often they appeared in public spaces. Programmes and interventions should focus on providing mental health services for LGBTI (lesbian, gay, bisexual, transgender and intersex) victims of violence, educating public security forces on the legal rights of Salvadorans and expanding current LGBTI-inclusive policies to all public security forces.

Experiences of gender-based violence among female sex workers, men who have sex with men, and transgender women in Latin America and the Caribbean: a qualitative study to inform HIV programming.

BACKGROUND: Female sex workers, MSM, and transgender women-collectively referred to as key populations (KPs)-are disproportionately affected by gender-based violence (GBV) and HIV, yet little is known about the violence they face, its gender-based origins, and responses to GBV. The purpose of this study was to understand the nature and consequences of GBV experienced, to inform HIV policies and programming and to help protect KPs' human rights. METHODS: Using a participatory approach, FSWs, MSM, and transgender women in Barbados, El Salvador, Trinidad and Tobago, and Haiti conducted 278 structured interviews with peers to understand their experiences of and responses to GBV. Responses to open-ended questions were coded in NVivo and analyzed using an applied thematic analysis. RESULTS: Nearly all participants experienced some form of GBV. Emotional and economic GBV were the most commonly reported but approximately three-quarters of participants reported sexual and physical GBV and other human rights violations. The most common settings for GBV were at home, locations where sex work took place such as brothels, bars and on the street; public spaces such as parks, streets and public transport, health care centers, police stations and-for transgender women and MSM-religious settings and schools. The most common perpetrators of violence included: family, friends, peers and neighbors, strangers, intimate partners, sex work clients and other sex workers, health care workers, police, religious leaders and teachers. Consequences included emotional, physical, and sexual trauma; lack of access to legal, health, and other social services; and loss of income, employment, housing, and educational opportunities. Though many participants disclosed experiences of GBV to friends, colleagues and family, they rarely sought services following violence. Furthermore, less than a quarter of participants believed that GBV put them at risk of HIV. CONCLUSIONS: Our study found that across the four study countries, FSWs, MSM, and transgender women experienced GBV from state and non-state actors throughout their lives, and much of this violence was directly connected to rigid and harmful gender norms. Through coordinated interventions that address both HIV and GBV, this region has the opportunity to reduce the national burden of HIV while also promoting key populations' human rights.

Effect of providing conditional economic compensation on uptake of voluntary medical male circumcision in Kenya: a randomized clinical trial.

IMPORTANCE: Novel strategies are needed to increase the uptake of voluntary medical male circumcision (VMMC) in sub-Saharan Africa and enhance the effectiveness of male circumcision as an HIV prevention strategy. OBJECTIVE: To determine whether small economic incentives could increase circumcision prevalence by addressing reported economic barriers to VMMC and behavioral factors such as present-biased decision making. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted between June 22, 2013, and February 4, 2014, among 1504 uncircumcised men aged 25 to 49 years in Nyanza region, Kenya. VMMC services were provided free of charge and participants were randomized to 1 of 3 intervention groups or a control group. INTERVENTIONS: Participants in the 3 intervention groups received varying amounts of compensation conditional on undergoing circumcision at 1 of 9 study clinics within 2 months of enrollment. Compensation took the form of food vouchers worth 200 Kenya shillings (≈ US $2.50), 700 Kenya shillings (≈ US $8.75), or 1200 Kenya shillings (≈ US $15.00), which reflected a portion of transportation costs and lost wages associated with getting circumcised. The control group received no compensation. MAIN OUTCOMES AND MEASURES: VMMC uptake within 2 months. RESULTS: Analysis of data for 1502 participants with complete data showed that VMMC uptake within 2 months was higher in the US $8.75 group (6.6%; 95% CI, 4.3%-9.5% [25 of 381]) and the US $15.00 group (9.0%; 95% CI, 6.3%-12.4% [34 of 377]) than in the US $2.50 group (1.9%; 95% CI, 0.8%-3.8% [7 of 374]) and the control group (1.6%; 95% CI, 0.6%-3.5% [6 of 370]). In logistic regression analysis, the US $8.75 group had significantly higher VMMC uptake than the control group (adjusted odds ratio [AOR] 4.3; 95% CI, 1.7-10.7), as did the US $15.00 group (AOR 6.2; 95% CI, 2.6-15.0). Effect sizes for the US $8.75 and US $15.00 groups did not differ significantly (P = .20). CONCLUSIONS AND RELEVANCE: Among uncircumcised men in Kenya, compensation in the form of food vouchers worth approximately US $8.75 or US $15.00, compared with lesser or no compensation, resulted in a modest increase in the prevalence of circumcision after 2 months. The effects of more intense promotion or longer implementation require further investigation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01857700.

Targeted solutions to increase dolutegravir coverage, viral load testing coverage, and viral suppression among children living with HIV in Togo: An analysis of routine facility data.

BACKGROUND: According to UNAIDS, Togo halved AIDS-related deaths among children ages 0-14 from 2010 to 2020. However, available data show low dolutegravir (DTG)-containing antiretroviral therapy (ART) coverage and low viral load suppression (VLS) among children living with HIV (CLHIV). We analyzed routine facility data before and after implementation of root-cause-based solutions for improving DTG coverage, viral load (VL) testing coverage, and VLS among CLHIV. DESCRIPTION: We analyzed routine data for CLHIV ≤14 years from October 2019 through September 2022. We assessed proportion of CLHIV on ART receiving DTG, VL testing coverage (CLHIV on ART with documented VL test result), and VLS (CLHIV with documented VL test result of <1,000 copies among those with test result). From October 2019 to September 2020, 52% were on a DTG-containing regimen, 48% had documented VL test results, and 64% had VLS. Site-level teams conducted a root-cause analysis and designed corresponding solutions implemented beginning October 2020: line listing and contacting eligible CLHIV to start/transition to DTG-containing regimen and collect VL samples; ART adherence support; monthly DTG stock monitoring; tracking pending VL test results through laboratory focal persons; documenting VL test results; and informing caregivers within one week if CLHIV not virally suppressed. Granular data were used to prioritize technical assistance to sites with lowest DTG coverage, VL testing coverage, and VLS. RESULTS: From baseline (October 2019-September 2020) to endline (October 2021-September 2022), increases were observed for DTG coverage (52% to 71%), VL testing coverage (48% to 90%), and VLS (64% to 82%). Age-disaggregated data showed positive trends. CONCLUSIONS: Root-cause-based solutions and granular data use increased DTG coverage, resulting in increased VL testing and VLS among CLHIV. These interventions should be scaled and become the national standard of care.

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.

Factors influencing uptake, continuation, and discontinuation of oral PrEP among clients at sex worker and MSM facilities in South Africa.

BACKGROUND: South Africa became the first country in Africa to introduce oral PrEP in June 2016. The National Department of Health has used a phased approach to rollout, allowing for a dynamic learn-and-adapt process which will lead ultimately to scale-up. Phased rollout began with provision of oral PrEP at facilities providing services to sex workers in 2016 and was expanded in 2017, first to facilities providing services to MSM and then to students at selected university campus clinics, followed by provision at primary health care facilities. Programmatic data shows variability in initiation and continuation between these populations. This study examines factors related to PrEP initiation, continuation, and discontinuation at facilities providing services to sex workers and MSM during the national PrEP rollout. METHODS: A cross-sectional survey was administered September 2017-January 2018 among clients (ages 18-62 and providers at 9 facilities implementing oral PrEP in South Africa, followed by in-depth interviews. The client survey captured PrEP initiation, continuation and discontinuation. Analysis was performed in STATA 13 for survey data and thematic analysis was performed in NViVO 11 for in-depth interview data. RESULTS: 299 clients (203 from sex worker facilities, 96 from MSM facilities) participated in the survey and additionally, in-depth interviews were conducted with 29 clients. Participants self-identified as either current users (n = 94; 36.2%), past users (n = 80; 30.8%) and never users of PrEP (n = 86; 33.1%). Participants who had never used PrEP either cited not being offered PrEP by a provider (57%, n = 49) or declining PrEP (43%, n = 37) as reasons for lack of uptake. The primary reason for declining to use oral PrEP was fear of side effects (41.7%, n = 15). The primary reasons for initiating and continuing on oral PrEP were all related to perceived risk associated with sexual activity. The majority of participants (87.9%, n = 153) also noted that printed IEC materials influenced their decision to initiate PrEP. Qualitative data suggested that several clients initiated on PrEP because they wanted additional protection beyond using condoms due to challenges such as partners refusing to use condoms, having partners with unknown HIV status, having multiple partners, involvement in sex work, or having a partner living with HIV. The majority (73.8%, n = 59) of participants who discontinued oral PrEP cited side effects as the primary reason for discontinuation, followed by feeling stigmatized (18.8%, n = 15). CONCLUSION: This study provides valuable insights on early rollout of PrEP of how clients perceive oral PrEP and where to target efforts to improve the uptake of this highly effective HIV prevention product. By identifying strengths and areas for improvement, the ACCESS study has generated evidence that can be used to guide high quality scale-up in South Africa and may be instructive for other countries' efforts to expand quality access to oral PrEP.

Reaching at-risk women for PrEP delivery: What can we learn from clinical trials in sub-Saharan Africa?

INTRODUCTION: ARV-based pre-exposure prophylaxis (PrEP) has the potential to avert many new HIV infections, yet little is known about how to reach women at high risk for HIV infection and motivate them to initiate PrEP. Clinical trials have succeeded in recruiting at-risk participants, evidenced by control arm HIV incidence ≥3% (defined by the World Health Organization as "substantial risk"). We examined experiences from HIV prevention trials to document recruitment strategies and identify practical, potentially effective strategies for reaching women in real-world PrEP delivery. METHODS: We conducted semi-structured qualitative phone interviews with 31 staff from five countries who had worked on one or more of seven ARV-based HIV prevention clinical trials. Questions explored recruitment strategies used to reach women at risk of HIV and to successfully communicate about PrEP (inclusive of oral and vaginal formulations). We structurally coded data in NVivo and analyzed codes to derive themes. We conducted results interpretation webinars with research and programmatic stakeholders to validate findings and develop recommendations. RESULTS: Clinical trial researchers employed a range of recruitment strategies to recruit at-risk women. They recommended engaging the local community and potential PrEP users via community events, meetings with gatekeepers, and use of community advisory boards; and they encouraged interpersonal communication like presentations in waiting rooms and door-to-door recruitment to address personal concerns and prevent misinformation. Participants also stressed the importance of addressing the challenges that already exist within the health system to create a more enabling environment and delivering positive messages through a variety of communication channels to normalize PrEP. CONCLUSIONS: Findings from this study provide important insights into potentially effective ways for countries currently rolling out oral PrEP to reach at-risk women with information about PrEP and promote uptake.

"We're Going to Leave You for Last, Because of How You Are": Transgender Women's Experiences of Gender-Based Violence in Healthcare, Education, and Police Encounters in Latin America and the Caribbean.

Transgender (trans) women experience gender-based violence (GBV) throughout their lives, which impedes their access to services and contributes to poor health outcomes and quality of life. To inform policies and health programs, trans women worked with the United States Agency for International Development (USAID)- and President's Emergency Plan for AIDS Relief (PEPFAR)-supported LINKAGES project, the United Nations Development Programme, The University of the West Indies, and local organizations to document experiences of GBV and transphobia in healthcare, education, and police encounters. Trans women conducted 74 structured interviews with other trans women in El Salvador, Trinidad and Tobago, Barbados, and Haiti in 2016. We conducted qualitative applied thematic analysis to understand the nature and consequences of GBV and transphobia and descriptive quantitative analysis to identify the proportion who experienced GBV in each context. A high proportion experienced GBV in education (85.1%), healthcare (82.9%), from police (80.0%), and other state institutions (66.1%). Emotional abuse was the most common in all contexts and included gossiping, insults, and refusal to use their chosen name. Participants also experienced economic, physical, and sexual violence, and other human rights violations based on their gender identity and expression. At school, participants were physically threatened and assaulted, harassed in bathrooms, and denied education. In healthcare, participants were given lower priority and received substandard care. Healthcare workers and police blamed participants for their health and legal problems, and denied them services. From police, participants also experienced physical and sexual assault, theft, extortion for sex or money, and arbitrary arrest and detention. Participants had difficulty obtaining identification documents that matched their gender identity, sometimes being forced to alter their appearance or being denied an identification card. Service providers not only failed to meet the specific needs of trans women but also discriminated against them when they sought services, exacerbating their economic, health, and social vulnerability. Although international and regional resolutions call for the legal protection of transgender people, states do not meet these obligations. To respect, promote, and fulfill trans women's human rights, governments should enact and enforce antidiscrimination and gender-affirming laws and policies. Governments should also sensitize providers to deliver gender-affirming services.

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.

Use of Economic Compensation to Increase Demand for Voluntary Medical Male Circumcision in Kenya: Qualitative Interviews With Male Participants in a Randomized Controlled Trial and Their Partners.

BACKGROUND: Interventions to increase demand for medical male circumcision are urgently needed in eastern and southern Africa. Following promising evidence that providing economic compensation can increase male circumcision uptake in Kenya, there is a need to understand the role of this intervention in individuals' decision-making regarding circumcision and explore perceptions of the intervention and concerns such as coercion. METHODS: As part of a randomized controlled trial in Kenya that found compensation in the form of food vouchers worth US $8.75-US $15.00 to be effective in increasing male circumcision uptake, we conducted qualitative in-depth interviews with 45 circumcised and uncircumcised male participants and 19 female partners to explore how compensation provision influenced the decision to get circumcised. Interview transcripts were coded and an inductive thematic analysis was conducted to identify patterns in decision-making. RESULTS: Interviews revealed that compensation promoted circumcision uptake by addressing a major barrier to male circumcision uptake: lost wages during and after the circumcision procedure. Participants who did not get circumcised perceived the compensation amounts to be insufficient for offsetting their costs associated with getting circumcised or reported having nonfinancial barriers that were not addressed by the intervention, such as fear of pain. Participants also reported that they did not feel compelled to get circumcised for financial gain. Female partners of circumcised participants felt that the intervention helped to motivate their partners to get circumcised. CONCLUSIONS: The results suggest that the provision of economic compensation is an acceptable intervention that can address an important barrier to male circumcision uptake. Providing compensation to circumcision clients in the form of food vouchers warrants further consideration in voluntary medical male circumcision demand creation efforts.

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.

Identifying and addressing barriers to uptake of voluntary medical male circumcision in Nyanza, Kenya among men 18-35: a qualitative study.

BACKGROUND: Uptake of VMMC among adult men has been lower than desired in Nyanza, Kenya. Previous research has identified several barriers to uptake but qualitative exploration of barriers is limited and evidence-informed interventions have not been fully developed. This study was conducted in 2012 to 1) increase understanding of barriers to VMMC and 2) to inform VMMC rollout through the identification of evidence-informed interventions among adult men at high risk of HIV in Nyanza Province, Kenya. METHODS: Focus groups (n = 8) and interviews were conducted with circumcised (n = 8) and uncircumcised men (n = 14) from the two districts in Nyanza, Kenya. Additional interviews were conducted with female partners (n = 20), health providers (n = 12), community leaders (n = 12) and employers (n = 12). Interview and focus group guides included questions about individual, interpersonal and societal barriers to VMMC uptake and ways to overcome them. Inductive thematic coding and analysis were conducted through a standard iterative process. RESULTS: Two primary concerns with VMMC emerged 1) financial issues including missing work, losing income during the procedure and healing and family survival during the recovery period and 2) fear of pain during and after the procedure. Key interventions to address financial concerns included: a food or cash transfer, education on saving and employer-based benefits. Interventions to address concerns about pain included refining the content of demand creation and counseling messages about pain and improving the ways these messages are delivered. CONCLUSIONS: Men need accurate and detailed information on what to expect during and after VMMC regarding both pain and time away from work. This information should be incorporated into demand creation activities for men considering circumcision. Media content should frankly and correctly address these concerns. Study findings support scale up and/or further improvement of these ongoing educational programs and specifically targeting the demand creation period.

Women's roles in voluntary medical male circumcision in Nyanza Province, Kenya.

Women are an important audience for voluntary medical male circumcision (VMMC) communication messages so that they know that VMMC provides only partial protection against HIV. They may also be able to influence their male partners to get circumcised and practice other HIV protective measures after VMMC. This study was conducted in two phases of qualitative data collection. Phase 1 used in-depth interviews to explore women's understanding of partial protection and their role in VMMC. Phase 2 built on the findings from the Phase 1, using focus groups to test VMMC communication messages currently used in Nyanza Province and to further explore women's roles in VMMC. Sixty-four sexually active women between the ages of 18 and 35 participated. In Phase 1, all women said they had heard of partial protection, though some were not able to elaborate on what the concept means. When women in Phase 2 were exposed to messages about partial protection, however, participants understood the messages well and were able to identify the main points. In Phases 1 and 2, many participants said that they had discussed VMMC with their partner, and for several, it was a joint decision for the man to go for VMMC. These findings suggest that current VMMC messaging is reaching women, though communications could more effectively target women to increase their ability to communicate about partial HIV protection from VMMC. Also, women seem to be playing an important role in encouraging men to get circumcised, so reaching out to women could be a valuable intervention strategy for increasing VMMC uptake and promoting use of other HIV protective measures after VMMC.

Increasing support for contraception as HIV prevention: stakeholder mapping to identify influential individuals and their perceptions.

BACKGROUND: Voluntary contraceptive use by HIV-positive women currently prevents more HIV-positive births, at a lower cost, than anti-retroviral drug (ARV) regimens. Despite this evidence, most prevention of mother-to-child transmission (PMTCT) programs focus solely on providing ARV prophylaxis to pregnant women and rarely include the prevention of unintended pregnancies among HIV-positive women. METHODOLOGY/PRINCIPAL FINDINGS: To strengthen support for family planning as HIV prevention, we systematically identified key individuals in the field of international HIV/AIDS-those who could potentially influence the issue-and sought to determine their perceptions of barriers to and facilitators for implementing this PMTCT strategy. We used a criteria-based approach to determine which HIV/AIDS stakeholders have the most significant impact on HIV/AIDS research, programs, funding and policy and stratified purposive sampling to conduct interviews with a subset of these individuals. The interview findings pointed to obstacles to strengthening linkages between family planning and HIV/AIDS, including the need for: resources to integrate family planning and HIV services, infrastructure or capacity to provide integrated services at the facility level, national leadership and coordination, and targeted advocacy to key decision-makers. CONCLUSIONS/SIGNIFICANCE: The individuals we identified as having regional or international influence in the field of HIV/AIDS have the ability to leverage an increasingly conducive funding environment and a growing evidence base to address the policy, programmatic and operational challenges to integrating family planning with HIV/AIDS. Fostering greater support for implementing contraception for HIV prevention will require the dedication, collaboration and coordination of many such actors. Our findings can inform a targeted advocacy campaign.