Drug-Drug Interactions between Antiretrovirals and Hormonal Contraception: An Updated Systematic Review.

OBJECTIVE: To summarize and update information regarding drug-drug interactions (DDIs) between antiretrovirals (ARVs) and hormonal contraceptives (HCs). DESIGN: Systematic review METHODS: We searched seven databases for peer-reviewed publications from January 1, 2015, through December 31, 2023, including studies of women using ARVs and HCs concurrently with outcomes including therapeutic effectiveness or toxicity, pharmacokinetics (PK), or pharmacodynamics. We summarized findings and used checklists to assess evidence quality. RESULTS: We included 49 articles, with clinical, ARV or HC PK outcomes reported by 39, 25, and 30 articles, respectively, with some articles reporting outcomes in two or more categories. Fifteen of 18 articles assessing DDIs between efavirenz and progestin implants, emergency contraception, or combined hormonal intravaginal rings found higher pregnancy rates, luteal progesterone levels suggesting ovulation, or reduced progestin PK values. Five studies documented that CYP2B6 single nucleotide polymorphisms exacerbated this DDI. One cohort detected doubled bone density loss with concomitant depot medroxyprogesterone acetate (DMPA) and tenofovir disoproxil fumarate (TDF)-containing ART use versus TDF alone. No other studies described DDIs impacting clinical outcomes. Few adverse events were attributed to ARV-HC use with none exceeding Grade 2. Evidence quality was generally moderate, with dis-similar treatment and control groups, identifying and controlling for confounding, and minimizing attrition bias in the study design being the most frequent limitations. CONCLUSION: Most ARVs and HCs may be used safely and effectively together. TDF-DMPA DDIs warrant longer-term study on bone health and consideration of alternate combinations. For efavirenz-based ART, client counselling on relative risks, including both potential increase in pregnancy rate with concomitant efavirenz and implant use and lower pregnancy rates compared to other HCs even with concomitant efavirenz use, should continue to allow users comprehensive method choice.

Health status of transgender people globally: A systematic review of research on disease burden and correlates.

BACKGROUND AND OBJECTIVES: Transgender and gender diverse (trans) health research has grown rapidly, highlighting the need to characterize the scientific evidence base. We conducted a systematic review of peer-reviewed research on disease burden and correlates in trans adolescents and adults over a 20-month period to identify knowledge gaps and assess methodological characteristics including measurement of gender identity, community engagement, and study quality. DATA SOURCES, ELIGIBILITY CRITERIA, AND SYNTHESIS METHODS: We searched seven databases using terms related to (a) transgender populations and (b) health or disease. Eligible studies were in English, French, or Spanish and reported original quantitative data on mental health or substance use conditions, infectious diseases, or non-communicable conditions in at least 25 trans individuals aged 15+. Quality assessment was performed in duplicate on a 10% sample of articles and findings were summarized using narrative synthesis. RESULTS: The 328 included studies were conducted in 45 countries, with most from North America (54%) and limited research from South Asia (3%), Sub-Saharan Africa (3%), and the Middle East and North Africa (2%). Most studies used cross-sectional designs (73%) and convenience sampling (65%). Only 30% of studies reported any form of community engagement. Mental health and substance use disorders were the most studied area (77% of studies) and non-communicable conditions the least (16%). Available data indicated that trans populations experience high disease burden with considerable heterogeneity within and across settings. Of 39 articles assessed for quality, 80% were rated as fair, 18% as poor, and 3% as good quality. CONCLUSIONS AND IMPLICATIONS: Geographic, gender-specific, and topical gaps remain in trans health, but we found more research from African countries, with transmasculine people, and on non-communicable conditions than previous syntheses. Areas for growth in trans health research include community engagement, non-binary health, chronic and age-related conditions, and health determinants. REGISTRATION: PROSPERO CRD42021234043.

Systematic review of the values and preferences regarding the use of injectable pre-exposure prophylaxis to prevent HIV acquisition.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) is an important HIV prevention option. Two randomized trials have provided efficacy evidence for long-acting injectable cabotegravir (CAB-LA) as PrEP. In considering CAB-LA as an additional PrEP modality for people at substantial risk of HIV, it is important to understand community response to injectable PrEP. We conducted a systematic review of values, preferences and perceptions of acceptability for injectable PrEP to inform global guidance. METHODS: We searched nine databases and conference websites for peer-reviewed and grey literature (January 2010-September 2021). There were no restrictions on location. A two-stage review process assessed references against eligibility criteria. Data from included studies were organized by constructs from the Theoretical Framework of Acceptability. RESULTS: We included 62 unique references. Most studies were observational, cross-sectional and qualitative. Over half of the studies were conducted in North America. Men who have sex with men were the most researched group. Most studies (57/62) examined injectable PrEP, including hypothetical injectables (55/57) or placebo products (2/57). Six studies examined CAB-LA specifically. There was overall interest in and often a preference for injectable PrEP, though there was variation within and across groups and regions. Many stakeholders indicated that injectable PrEP could help address adherence challenges associated with daily or on-demand dosing for oral PrEP and may be a better lifestyle fit for individuals seeking privacy, discretion and infrequent dosing. End-users reported concerns, including fear of needles, injection site pain and body location, logistical challenges and waning or incomplete protection. DISCUSSION: Despite an overall preference for injectable PrEP, heterogeneity across groups and regions highlights the importance of enabling end-users to choose a PrEP modality that supports effective use. Like other products, preference for injectable PrEP may change over time and end-users may switch between prevention options. There will be a greater understanding of enacted preference as more end-users are offered anti-retroviral (ARV)-containing injectables. Future research should focus on equitable implementation, including real-time decision-making and how trained healthcare providers can support choice. CONCLUSIONS: Given overall acceptability, injectable PrEP should be included as part of a menu of prevention options, allowing end-users to select the modality that suits their preferences, needs and lifestyle.

Synthesis of end-user research to inform future multipurpose prevention technologies in sub-Saharan Africa: a scoping review.

Introduction: Women in sub-Saharan Africa (SSA) experience disproportionately high rates of HIV infection and unintended pregnancy compared to their age-matched counterparts in other regions of the world. Multipurpose prevention technologies (MPTs) that offer protection against HIV and unintended pregnancy in a single product stand to address these dual sexual and reproductive health needs simultaneously. The aim of this scoping review is to identify factors that are important for optimizing the likelihood of MPT adoption by end users in SSA. Methods: Study inclusion criteria included MPT research (HIV and pregnancy prevention dual indication) published or presented in English from 2000 to 2022 and conducted in SSA amongst end-users (women aged 15-44), male partners, health care providers, and community stakeholders. References were identified by searching peer reviewed literature, grey literature, conference presentations (2015-2022), grant databases, and outreach to MPT subject matter experts. Of 115 references identified, 37 references met inclusion criteria and were extracted for analysis. A narrative synthesis approach was used to summarize findings within and across MPT products. Results: Studies were identified from six countries in SSA and a substantial proportion included a South African (n = 27) and/or Kenyan (n = 16) study site. Most studies utilized a qualitative study design (n = 22) and evaluated MPT acceptability and preferences by presenting hypothetical products through images or a list of product attributes (n = 21). The vaginal ring (n = 20), oral tablet (n = 20), and injection (n = 15) were examined most frequently. Across studies, there was high acceptability and demand for an HIV and pregnancy prevention MPT. End users valued choice in prevention product type as well as discreetness and long-acting options. Provider counseling and community sensitization were reported as essential for future introduction of novel MPT delivery forms. Conclusion: Recognizing the heterogeneity of women's preferences and changing reproductive and sexual health needs over the life course, choice is important in the delivery of pregnancy and HIV prevention products as well as amongst MPT products with distinct product profiles. End user research with active MPTs, vs. hypothetical or placebo MPTs, is necessary to advance understanding of end-user preferences and acceptability of future products.

Safety and efficacy of long-acting injectable cabotegravir as preexposure prophylaxis to prevent HIV acquisition.

OBJECTIVE: HIV remains a significant burden, despite expanding HIV prevention tools. Long-acting injectable cabotegravir (CAB-LA) is a new preexposure prophylaxis (PrEP) product. We reviewed existing evidence to determine the efficacy and safety of CAB-LA as PrEP to inform global guidelines. DESIGN: Systematic review and meta-analysis. METHODS: We systematically reviewed electronic databases and conference abstracts for citations on CAB-LA from January 2010 to September 2021. Outcomes included HIV infection, adverse events, drug resistance, pregnancy-related adverse events, and sexual behavior. We calculated pooled effect estimates using random-effects meta-analysis and summarized other results narratively. RESULTS: We identified 12 articles/abstracts representing four multisite randomized controlled trials. Study populations included cisgender men, cisgender women, and transgender women. The pooled relative risk of HIV acquisition comparing CAB-LA to oral PrEP within efficacy studies was 0.21 (95% confidence interval: 0.07-0.61), resulting in a 79% reduction in HIV risk. Rates of adverse events were similar across study groups. Of 19 HIV infections among those randomized to CAB-LA with results available, seven had integrase strand transfer inhibitor (INSTI) resistance. Data on pregnancy-related adverse events were sparse. No studies reported on sexual behavior. CONCLUSIONS: CAB-LA is highly efficacious for HIV prevention with few safety concerns. CAB-LA may lead to an increased risk of INSTI resistance among those who have acute HIV infection at initiation or become infected while taking CAB-LA. However, results are limited to controlled studies; more research is needed on real-world implementation. Additional data are needed on the safety of CAB-LA during pregnancy (for mothers and infants) and among populations not included in the trials.

Caregiver Social Capital and Supportive Relationships are Associated with Better Child Social-Emotional Development.

This study examined how different domains of social capital and of social support among caregivers are associated with social-emotional development in children ages 4-6 and how caregiver depressive symptoms modify these associations. Using a stratified random sample of preschools, data included a cross-sectional study of 1147 child-caregiver pairs (543 girls) in a low-income municipality in Brazil. Crude and adjusted linear regression models revealed that all domains of social support and two domains of social capital were associated with less social-emotional development delay in children. Given a significant proportion of children in low- and middle-income countries do not meet developmental milestones, strengthening caregiver social capital and support in these settings may have the potential to improve child social-emotional development.

Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world.

OBJECTIVE: The vaginal ring (ring) is a female-initiated, long-acting drug delivery system for different indications, including HIV prevention. Our aim was to provide evidence for acceptability of the vaginal ring across indications to support dapivirine and multipurpose prevention technology ring introduction and roll out. STUDY DESIGN: This systematic review and meta-analysis followed PRISMA guidelines. We searched PubMed, Web of Science, Embase, and grey literature for publications reporting favorable ring acceptability and secondary outcomes involving actual ring use (comfort, ease of ring use, ring comfort during sex, expulsions, and vaginal symptoms) or hypothetical acceptability for any indication published January 1, 1970-June 15, 2021. We estimated random-effects pooled prevalence, assessing between-study variation using meta-regression. RESULTS: Of 2,234 records, we included 123 studies with 40,434 actual and hypothetical ring users. The primary outcome assessment included 50 studies with 60 ring subgroups totaling 19,271 ring users. The favorable acceptability pooled prevalence was 85.6% (95%CI 81.3, 89.0), while hypothetical acceptability among non-ring users was 27.6% (95%CI 17.5, 40.5). In meta-regression, acceptability was higher in menopause (95.4%; 95%CI 88.4, 98.2) compared to contraceptive rings (83.7%; 95%CI 75.6, 89.5). Acceptability was lower in pharmacokinetic studies (50%; 95%CI 22.1, 77.9) compared to RCTs (89.5%; 95%CI 85.8.92.4) and in studies assessing acceptability at ≥12 months (78.5%; 95%CI 66.5, 87.1) versus studies assessing acceptability at <3 months (91.9%; 95%CI 83.7, 96.1). European (90.6%; 95%CI 83.9, 94.7), Asian (97.1%; 95%CI 92.0, 99.0), and multi-region studies (93.5%; 95%CI 84.6, 97.4) reported more favorable acceptability compared to African studies (59.4%; 95%CI 38.3, 77.5). Secondary outcomes were similarly favorable, including ring comfort (92.9%; 95%CI 89.2, 95.4), ease of use (90.9%; 95%CI 86.5, 94.0), and comfort during sex (82.7%; 95%CI 76.4, 87.6). Limitations include inconsistent outcome definitions and unmeasured factors affecting acceptability. CONCLUSIONS: Women who used vaginal rings reported they were acceptable across indications geographic regions and indications. Policy makers should consider the ring as an important option for pregnancy and HIV prevention drug development. IMPLICATIONS: This review found favorable acceptability among vaginal ring users across indications and geographic areas, in contrast to low hypothetical acceptability among non-users. Vaginal rings are an important drug delivery system for pregnancy and HIV preventions, and scale-up should plan to address initial hesitancy among new users.

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.

Test and Prevent: Evaluation of a Pilot Program Linking Clients With Negative HIV Test Results to Pre-exposure Prophylaxis in Zimbabwe.

BACKGROUND: As HIV testing increases worldwide, programs are reaching individuals without HIV infection who are at risk of exposure and may be candidates for oral pre-exposure prophylaxis (PrEP). Although linkage of individuals with HIV infection to treatment is a global priority (referred to as "test and treat"), less attention is given to individuals with negative HIV test results. We developed the "Test and Prevent" pilot program to intentionally link at-risk clients with negative HIV test results to PrEP services. The intervention included risk assessment of all clients with a negative result from HIV testing (with national risk assessment tool), accompanied referral, fast-tracking, and targeting follow-up. METHODS: The intervention was conducted in Bulawayo, Zimbabwe, at 6 public sector sites from October 2019 to February 2020. We collected routine monitoring data from all study sites and tracked referral completion and PrEP initiation among clients who enrolled. We conducted in-depth interviews with providers (n=12), facility managers (n=5), and female clients (n=17) to explore acceptability. RESULTS: Among clients referred for PrEP (n=206), 98% completed their referrals and started PrEP. However, only 3% of clients who received a negative test result during the study period were referred. Low referrals stemmed from lack of screening (39% of clients with negative HIV test results were not screened) and lack of eligibility among clients who were screened (only 6% of those screened qualified as candidates for PrEP per the national screening tool). Qualitative results indicate that some providers purposefully did not complete screening with clients they felt were not at risk and that workload could have contributed to low screening uptake.Qualitative interviews showed that Test and Prevent was acceptable among both providers and clients. Clients were happy to learn about PrEP following HIV testing, and the additional support of accompanied referrals and fast-tracking encouraged them to access PrEP and made them feel valued. Providers were burdened by workload constraints but felt that Test and Prevent was important and should be scaled to other sites. CONCLUSION: Intentionally linking clients with negative results to PrEP immediately following HIV testing was found to be acceptable from both provider and client perspectives, yet screening procedures need closer examination and reinforcement for the program to realize a larger impact.

Reproductive empowerment and contraceptive self-care: a systematic review.

Contraceptive self-care interventions are a promising approach to improving reproductive health. Reproductive empowerment, the capacity of individuals to achieve their reproductive goals, is recognised as a component of self-care. An improved understanding of the relationship between self-care and empowerment is needed to advance the design, implementation and scale-up of self-care interventions. We conducted a systematic review of the peer-reviewed and grey literature published from 2010 through 2020 to assess the relationship between reproductive empowerment and access, acceptability, use or intention to use contraceptive self-care. Our review adheres to PRISMA guidelines and is registered in PROSPERO (ID CRD42020205235). A total of 3036 unique records were screened and 37 studies met our inclusion criteria. Most studies were conducted in high-income countries, were cross-sectional and had high risk of bias. Almost half included only women. Over 80% investigated male condoms. All but one study focused on use of self-care. We found positive relationships between condom use self-efficacy and use of/intention to use condoms. We found similar evidence for other self-care contraceptive methods, but the low number of studies and quality of the evidence precludes drawing strong conclusions. Few studies assessed causal relationships between empowerment and self-care, indicating that further research is warranted. Other underexplored areas include research on power with influential groups besides sexual partners, methods other than condoms, and access and acceptability of contraceptive self-care. Research using validated empowerment measures should be conducted in diverse geographies and populations including adolescents and men.

'I married when I was 16 due to poverty, I had no other way': multi-level factors influencing HIV-related sexual risk behaviours among adolescent girls in Zambézia, Mozambique.

This paper explores individual, interpersonal- and household-level factors influencing HIV-related sexual risk behaviour among adolescent girls who participated in an intervention to reduce HIV risk in a rural setting in Mozambique. Twenty-eight adolescent girls ages 13-19, 30 heads of household, and 53 influential men participated in in-depth interviews at two time points. Comparative analysis compared girls who reported reducing risk behaviours over time to girls who did not and identified factors that respondents described as influential to behaviour change. Among the twenty girls self-reporting sexual risk at the first time point, half had reduced these behaviours one year later. Changes in girls' behaviours were contingent upon household- and interpersonal-level factors, particularly households' economic stability and family members' financial support. Future interventions with adolescents in similar settings should evaluate and leverage household and family support to achieve sexual risk reduction.

A Social Media-Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial.

BACKGROUND: Youth living with HIV (YLHIV) enrolled in HIV treatment experience higher loss to follow-up, suboptimal treatment adherence, and greater HIV-related mortality compared with younger children or adults. Despite poorer health outcomes, few interventions target youth specifically. Expanding access to mobile phone technology, in low- and middle-income countries (LMICs) in particular, has increased interest in using this technology to improve health outcomes. mHealth interventions may present innovative opportunities to improve adherence and retention among YLHIV in LMICs. OBJECTIVE: This study aimed to test the effectiveness of a structured support group intervention, Social Media to promote Adherence and Retention in Treatment (SMART) Connections, delivered through a social media platform, on HIV treatment retention among YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support. METHODS: We conducted a parallel, unblinded randomized controlled trial. YLHIV enrolled in HIV treatment for less than 12 months were randomized in a 1:1 ratio to receive SMART Connections (intervention) or standard of care alone (control). We collected data at baseline and endline through structured interviews and medical record extraction. We also conducted in-depth interviews with subsets of intervention group participants. The primary outcome was retention in HIV treatment. We conducted a time-to-event analysis examining time retained in treatment from study enrollment to the date the participant was no longer classified as active-on-treatment. RESULTS: A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172). Our primary analysis included data from 324 participants at endline. The probability of being retained in treatment did not differ significantly between the 2 study arms during the study. Retention was high at endline, with 75.7% (112/163) of intervention group participants and 83.4% (126/161) of control group participants active on treatment. HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support. Intervention group participants overwhelmingly reported that the intervention was useful, that they enjoyed taking part, and that they would recommend it to other YLHIV. CONCLUSIONS: Our findings of improved HIV knowledge and high acceptability are encouraging, despite a lack of measurable effect on retention. Retention was greater than anticipated in both groups, likely a result of external efforts that began partway through the study. Qualitative data indicate that the SMART Connections intervention may have contributed to retention, adherence, and social support in ways that were not captured quantitatively. Web-based delivery of support group interventions can permit people to access information and other group members privately, when convenient, and without travel. Such digital health interventions may help fill critical gaps in services available for YLHIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT03516318; https://clinicaltrials.gov/ct2/show/NCT03516318.

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.

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.

Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis.

The vaginal ring (VR) is a female-initiated drug-delivery platform used for different indications, including HIV pre-exposure prophylaxis (PrEP). We conducted a systematic review of VR acceptability, values and preferences among women in low- and middle-income countries (LMIC) to inform further investment and/or guidance on VR use for HIV prevention. Following PRISMA guidelines, we used structured methods to search, screen, and extract data from randomized controlled trials (RCTs) and observational studies reporting quantitative outcomes of acceptability of the VR for any indication published 1/1970-2/2019 (PROSPERO: CRD42019122220). Of 1,110 records identified, 68 met inclusion criteria. Studies included women 15-50+ years from 25 LMIC for indications including HIV prevention, contraception, abnormal bleeding, and menopause. Overall VR acceptability was high (71-98% across RCTs; 62-100% across observational studies), with 80-100% continuation rates in RCTs and favorable ease of insertion (greater than 85%) and removal 89-99%). Users reported concerns about the VR getting lost in the body (8-43%), although actual expulsions and adverse events were generally infrequent. Most women disclosed use to partners, with some worrying about partner anger/violence. The VR was not felt during intercourse by 70-92% of users and 48-97% of partners. Acceptability improved over time both within studies (as women gained VR experience and worries diminished), and over chronological time (as the device was popularized). Women expressed preferences for accessible, long-acting, partner-approved methods that prevent both HIV and pregnancy, can be used without partner knowledge, and have no impact on sex and few side effects. This review was limited by a lack of standardization of acceptability measures and study heterogeneity. This systematic review suggests that most LMIC women users have a positive view of the VR that increases with familiarity of use; and, that many would consider the VR an acceptable future delivery device for HIV prevention or other indications.

A longitudinal qualitative evaluation of an economic and social empowerment intervention to reduce girls' vulnerability to HIV in rural Mozambique.

PURPOSE: An intervention including business training and health education was implemented in Mozambique, where girls are at elevated risk for acquiring HIV. As part of a mixed-methods evaluation, we describe perceived effects of the intervention on girls' sexual behavior and school attendance. METHODS: We conducted 49 in-depth interviews (IDIs) with girl intervention participants (ages 13-19), 24 IDIs with heads of girls' households, 36 IDIs with influential males identified by girls, and 12 focus group discussions with community members after the intervention ended and one year later. RESULTS: Informants said the primary intervention benefit was realized when girls had money to stay in or return to school and/or to buy necessities for themselves and their households-reducing their need for transactional or intergenerational sex. However, some girls did not make a profit and some businesses were not sustainable. Sometimes the intervention appeared to be implemented in a way to reinforce inequitable gender norms resulting in some girls feeling shame when they reengaged in risky sex after their businesses failed. CONCLUSIONS: Earning money enabled girls to potentially reduce their vulnerability to HIV. We offer recommendations for future multi-sector interventions, including the need to address potential harms in programs serving vulnerable girls.

"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.

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.