Post-trial access to and use of pre-exposure prophylaxis in Durban, South Africa.

BACKGROUND: HIV endpoint-driven clinical trials increasingly provide oral pre-exposure prophylaxis (PrEP) as standard of prevention during the trial, however, among participants desiring to continue using PrEP at trial exit, little is known about post-trial PrEP access and continued use. METHODS: We conducted one-time, semi-structured, face-to-face, in-depth interviews with 13 women from Durban, South Africa, from November to December 2021. We interviewed women who initiated oral PrEP as part of the HIV prevention package during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial, elected to continue using PrEP at study exit, and were given a 3-month PrEP supply and referred to facilities for PrEP refills at the final trial visit. The interview guide probed for barriers and enablers to post-trial PrEP access, and current and future PrEP use. Interviews were audio-recorded and transcribed. Thematic analysis was facilitated using NVivo. RESULTS: Of the 13 women, six accessed oral PrEP post-trial exit, but five later discontinued. The remaining seven women did not access PrEP. Barriers to post-trial PrEP access and continued use included PrEP facilities having long queues, inconvenient operating hours, and being located far from women's homes. Some women were unable to afford transport costs to collect PrEP. Two women reported visiting their local clinics and requesting PrEP but were informed that PrEP was unavailable at the clinic. Only one woman was still using PrEP at the time of the interview. She reported that the PrEP facility was located close to her home, staff were friendly, and PrEP education and counselling were provided. Most women not on PrEP reported wanting to use it again, particularly if barriers to access could be alleviated and PrEP was easily available at facilities. CONCLUSIONS: We identified several barriers to post-trial PrEP access. Strategies to enhance PrEP access such as a reduction in waiting queues, convenient facility operating hours, and making PrEP more widely available and accessible are needed. It is also worth noting that oral PrEP access has expanded in South Africa from 2018 till now and this could improve access to PrEP for participants exiting trials who desire to continue PrEP.

Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial.

BACKGROUND: South Africa (SA) has the greatest HIV prevalence in the world, with rates as high as 40% among pregnant women. Depression is a robust predictor of nonadherence to antiretroviral therapy (ART) and engagement in HIV care; perinatal depression may affect upwards of 47% of women in SA. Evidence-based, scalable approaches for depression treatment and ART adherence in this setting are lacking. METHOD: Twenty-three pregnant women with HIV (WWH), ages 18-45 and receiving ART, were randomized to a psychosocial depression and adherence intervention or treatment as usual (TAU) to evaluate intervention feasibility, acceptability, and preliminary effect on depressive symptoms and ART adherence. Assessments were conducted pre-, immediately post-, and 3 months post-treatment, and included a qualitative exit interview. RESULTS: Most (67.6%) eligible individuals enrolled; 71% completed at least 75% of sessions. Compared to TAU, intervention participants had significantly greater improvements in depressive symptoms at post-treatment, ß = - 11.1, t(24) = - 3.1, p < 0.005, 95% CI [- 18.41, - 3.83], and 3 months, ß = - 13.8, t(24) = - 3.3, p < 0.005, 95% CI [- 22.50, - 5.17]. No significant differences in ART adherence, social support, or stigma were found. Qualitatively, perceived improvements in social support, self-esteem, and problem-solving adherence barriers emerged as key benefits of the intervention; additional sessions were desired. CONCLUSION: A combined depression and ART adherence intervention appears feasible and acceptable, and demonstrated preliminary evidence of efficacy in a high-need population. Additional research is needed to confirm efficacy and identify dissemination strategies to optimize the health of WWH and their children. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03069417. Protocol available at https://clinicaltrials.gov/ct2/show/NCT03069417.

Key stakeholders' perspectives on providing oral pre-exposure prophylaxis as HIV-prevention standard of care in clinical trials in South Africa.

Introduction: HIV-prevention and endpoint-driven clinical trials enrol individuals at substantial risk of HIV. Recently, these trials have provided oral pre-exposure prophylaxis (PrEP) as HIV-prevention standard of care; however, data on PrEP uptake and use during the trial and post-trial access are lacking.Methods: We conducted once-off, telephonic, in-depth interviews from August 2020 to March 2021, with 15 key stakeholders (including site directors/leaders, principal investigators and clinicians), purposively recruited from research sites across South Africa that are known to conduct HIV-prevention and endpoint-driven clinical trials. The interview guide probed for facilitators and barriers to PrEP uptake and use during the trial, and post-trial PrEP access. Interviews were audio recorded and transcribed. Coding was facilitated using NVivo and emergent themes were identified.Results: Most stakeholders reported incorporating PrEP as part of the HIV-prevention package in HIV-prevention and endpoint-driven clinical trials. Stakeholders identified multiple barriers to PrEP uptake and use, including difficulties with daily pill taking, side effects, stigma, a lack of demand creation and limited knowledge and education about PrEP in communities. Facilitators of PrEP uptake and use included demand-creation campaigns and trial staff providing quality counselling and education. Post-trial PrEP access was frequently challenging as facilities were located a considerable distance from research sites, had long queues and inconvenient operating hours.Conclusions: Strategies to address barriers to PrEP uptake and use during trials and post-trial access, such as PrEP demand creation, education and counselling, addressing stigma, support for daily pill-taking and increased post-trial access, are urgently needed.

Daily Oral Pre-exposure Prophylaxis (PrEP) Continuation Among Women from Durban, South Africa, Who Initiated PrEP as Standard of Care for HIV Prevention in a Clinical Trial.

HIV incidence among women in Eastern and Southern Africa remains unacceptably high, highlighting the need for effective HIV prevention options, including pre-exposure prophylaxis (PrEP). The Evidence for Contraceptive Options and HIV Outcomes trial offered daily oral PrEP to participants during the latter part of the clinical trial as an additional HIV prevention choice. We explored daily oral PrEP continuation at trial exit among women enrolled from Durban, South Africa who initiated oral PrEP at the trial site. Of the 132 women initiating oral PrEP, 87% reported continuation of oral PrEP at month 1, 80% at month 3, and 75% continued using oral PrEP at their final trial visit and were referred to off-site facilities for ongoing oral PrEP access. The median duration of oral PrEP use in trial participants who used oral PrEP was 91 days (IQR 87 to 142 days). Women who disclosed their oral PrEP use to someone had increased odds of continuing oral PrEP at trial exit. Women who reported > 1 sex partner and those who felt they would probably or definitely get infected with HIV had reduced odds of continuing oral PrEP at trial exit. Of those discontinuing oral PrEP (n = 32), > 50% discontinued within the first month, and the most common reason for discontinuation was reporting side effects. The high rates of oral PrEP continuation in our study are encouraging and our findings can be utilized by other clinical trials providing oral PrEP as standard of care for HIV prevention and by oral PrEP implementation programmes.

Color, Scent and Size: Exploring Women's Preferences Around Design Characteristics of Drug-Releasing Vaginal Rings.

Steroid-releasing vaginal rings are available for contraception and estrogen replacement therapy, and a new antiretroviral-releasing ring was recently approved for HIV prevention. Marketed rings are white or transparent in appearance, non-scented, and supplied as one-size-fits-all devices with diameters ranging from 54 to 56 mm. In this study, drug-free silicone elastomer rings were manufactured in different sizes, colors and scents, and the opinions/preferences of 16 women (eThekwini District, South Africa; 20-34 years) assessed through focus group discussions and thematic analysis. Opinions varied on ring color and scent, with some women preferring specific colors or scent intensities, while for others these attributes were unimportant. Concerns about color and scent were linked to perceptions around vaginal health and safety related to chemical composition. There was greater agreement on preferred ring size; flexibility and width were considered important factors for insertion and comfort. Greater choice with ring products could facilitate acceptability and overall uptake.

Food insecurity and depression: a cross-sectional study of a multi-site urban youth cohort in Durban and Soweto, South Africa.

OBJECTIVE: To assess the prevalence of food insecurity and the independent association between depression and food insecurity among youth living in two urban settings in South Africa. METHODS: Baseline cross-sectional survey data was analysed from a prospective cohort study conducted between 2014 and 2016 among youth (aged 16-24 years) in Soweto and Durban. Interviewer-administered questionnaires collecting socio-demographic, sexual and reproductive health and mental health data were conducted. Household food insecurity was measured using the 3-item Household Hunger Scale, with food insecure participants defined as having 'moderate' or 'severe hunger' compared to 'no hunger'. Depression was assessed using the 10-item Center for Epidemiological Studies Depression (CES-D 10) Scale (range 0-30, probable depression ≥ 10). Multivariable logistic regression models were used to estimate the association between depression and food insecurity. RESULTS: There were 422 participants. Median age was 19 years (interquartile range [IQR] 18-21) and 60% were women. Overall, 18% were food insecure and 42% had probable depression. After adjustment for socio-demographic variables (age, gender, female-headed household, household size and school enrolment), participants with probable depression had higher odds of being food insecure than non-depressed participants (2.79, 95%CI 1.57-4.94). CONCLUSION: Nearly one-fifth of youth in this study were food insecure. Those with probable depression had increased odds of food insecurity. Interventions are needed to address food insecurity among urban youth in South Africa, combining nutritional support and better access to quality food with mental health support.

Exploring the Use of Oral Pre-exposure Prophylaxis (PrEP) Among Women from Durban, South Africa as Part of the HIV Prevention Package in a Clinical Trial.

HIV endpoint-driven clinical trials in Africa enroll women who are at heightened risk of acquiring HIV. In 2017, the South African Medical Research Council recommended the provision of oral pre-exposure prophylaxis (PrEP) in HIV prevention trials, at which time the Evidence for Contraceptive Options and HIV Outcomes trial was ongoing and began to provide PrEP on-site at some trial sites. We interviewed 132 women who initiated PrEP on-site at the Durban, South Africa trial site to explore PrEP use, and conducted phone-based interviews 4-6 months post-trial exit to explore post-trial PrEP access. PrEP uptake was high (42.6%). Among women initiating PrEP on-site, 87.9% felt at risk of acquiring HIV. Most women (> 90%) heard of PrEP for the first time from study staff and three-quarters who initiated PrEP on-site continued at trial-exit. PrEP use declined post-trial exit with more than 50% of women discontinuing PrEP, and barriers relating to access emerged.

Preferences and Acceptability of Vaginal Delivery Forms for HIV Prevention Among Women, Male Partners and Key Informants in South Africa and Zimbabwe: Qualitative Findings.

The attributes of an HIV microbicide may affect its acceptability, uptake and use. Quatro, a clinical study with a qualitative component, was conducted to elicit input from end-users and key informants (KIs) on four different placebo vaginal microbicide delivery forms; fast dissolving insert, ring, film and gel. In-depth interviews and focus group discussions were conducted with young women, their male partners and KIs, to explore acceptability and preferences of the four placebo products, with the intention of improving product attributes, adherence, and consequently, long term effectiveness. None of the four microbicide delivery forms stood well above others as the most preferred. Product attributes; long-action, ease of use, invisibility, female initiated and non-interference during sex were favourable in both countries. Despite preference for the long-action, on-demand products were the most liked by women. Qualitative data from the Quatro study provided rich feedback on specific attributes important to the acceptability of four HIV prevention product platforms currently in development, enabling more informed and guided product development efforts moving forward.

Efficacy is Not Everything: Eliciting Women's Preferences for a Vaginal HIV Prevention Product Using a Discrete-Choice Experiment.

As new female-initiated HIV prevention products enter development, it is crucial to incorporate women's preferences to ensure products will be desired, accepted, and used. A discrete-choice experiment was designed to assess the relative importance of six attributes to stated choice of a vaginally delivered HIV prevention product. Sexually active women in South Africa and Zimbabwe aged 18-30 were recruited from two samples: product-experienced women from a randomized trial of four vaginal placebo forms and product-naïve community members. In a tablet-administered survey, 395 women chose between two hypothetical products over eight choice sets. Efficacy was the most important, but there were identifiable preferences among other attributes. Women preferred a product that also prevented pregnancy and caused some wetness (p < 0.001). They disliked a daily-use product (p = 0.002) and insertion by finger (p = 0.002). Although efficacy drove preference, wetness, pregnancy prevention, and dosing regimen were influential to stated choice of a product, and women were willing to trade some level of efficacy to have other more desired attributes.

Mapping a Syndemic of Psychosocial Risks During Pregnancy Using Network Analysis.

BACKGROUND: Psychosocial risks during pregnancy impact maternal health in resource-limited settings, and HIV-positive women often bear a heavy burden of these factors. This study sought to use network modeling to characterize co-occurring psychosocial risks to maternal and child health among at-risk pregnant women. METHODS: Two hundred pregnant HIV-positive women attending antenatal care in South Africa were enrolled. Measured risk factors included younger age, low income, low education, unemployment, unintended pregnancy, distress about pregnancy, antenatal depression, internalized HIV stigma, violence exposure, and lack of social support. Network analysis between risk factors was conducted in R using mixed graphical modeling. Centrality statistics were examined for each risk node in the network. RESULTS: In the resulting network, unintended pregnancy was strongly tied to distress about pregnancy. Distress about pregnancy was most central in the network and was connected to antenatal depression and HIV stigma. Unintended pregnancy was also associated with lack of social support, which was itself linked to antenatal depression, HIV stigma, and low income. Finally, antenatal depression was connected to violence exposure. CONCLUSIONS: Our results characterize a network of psychosocial risks among pregnant HIV-positive women. Distress about pregnancy emerged as central to this network, suggesting that unintended pregnancy is particularly distressing in this population and may contribute to further risks to maternal health, such as depression. Prevention of unintended pregnancies and interventions for coping with unplanned pregnancies may be particularly useful where multiple risks intersect. Efforts addressing single risk factors should consider an integrated, multilevel approach to support women during pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03069417.

Functional performance study of an adapted design of the woman's condom: a crossover, noninferiority, randomized clinical trial.

Objectives: We aimed to assess the functional performance and safety of a modified Woman's Condom (WC2) against the existing FC2 female condom. Study design: This randomized clinical trial enrolled 287 women in one South African site. The primary outcome of the study was the rate of female condom failure. Participants were asked to use five of each female condom type and to collect information on use in a condom log at home and were interviewed after use of each FC type. Results: Noninferiority was demonstrated for the WC2 with respect to the reference condom FC2 for all condom functions. The WC2 was found to be superior to the FC2 reference condom for clinical failure (p = .000), total female condom failure (p = .001), misdirection (p = .000) and slippage (p = .004). Conclusion: The WC2 female condom performs as well as the FC2 female condom and offers good stability during use. Implications: Results from this study will inform further refinement of this female condom design, resulting in a new and potentially less expensive Woman's Condom.

Effect of a 'diagonal' intervention on uptake of HIV and reproductive health services by female sex workers in three sub-Saharan African cities.

OBJECTIVES: To enhance uptake of sexual and reproductive health (SRH) services by female sex workers (FSWs), we conducted an implementation study in which we piloted and tested context-specific 'diagonal' interventions, combining vertical, targeted interventions with horizontally improved access to the general health services, in three cities in sub-Saharan Africa. METHODS: We collected indicators of SRH service uptake through face-to-face interviews with approximately 400 FSWs, pre- and post-intervention, in Durban, South Africa; Tete, Mozambique; and Mombasa, Kenya, recruited by respondent-driven sampling. Changes in uptake were tested for their statistical significance using multivariate logistic regression models. RESULTS: In all cities, overall uptake of services increased. Having used all services for contraception, STI care, HIV testing, HIV care, cervical cancer screening and sexual violence, if needed, increased from 12.5% to 41.5% in Durban, 25.0% to 40.1% in Tete and 44.9% to 69.1% in Mombasa. Across cities, the effect was greatest in having been tested for HIV in the past six months which increased from 40.9% to 83.2% in Durban, 56.0% to 76.6% in Tete and 70.9% to 87.6% in Mombasa. In Tete and Mombasa, rise in SRH service use was almost entirely due to a greater uptake of targeted services. Only in Durban was there additionally an increase in the utilisation of general health services. CONCLUSION: SRH service utilisation improved in the short-term in three different sub-Saharan African contexts, primarily through vertical, targeted components. The long-term effectiveness of diagonal approaches, in particular on the use of general, horizontal health services, needs further investigation.

A Randomized Crossover Study Evaluating the Use and Acceptability of the SILCS Diaphragm Compared to Vaginal Applicators for Vaginal Gel Delivery.

INTRODUCTION: This study aimed to assess acceptability and preferences for the SILCS diaphragm for vaginal gel delivery compared to a prefilled applicator. METHODS: A randomized crossover study among 115 women in South Africa, using both methods during five sex acts. RESULTS: We found no significant differences in acceptability between the two products. Experience of gel leakage after sex was greater when inserted via applicator. More women were interested in SILCS/gel for multipurpose protection (68%) than in either SILCS alone (17%) or microbicide gel alone (14%). CONCLUSIONS: A SILCS gel delivery system for multipurpose prevention seems feasible and acceptable.

A high burden of asymptomatic genital tract infections undermines the syndromic management approach among adolescents and young adults in South Africa: implications for HIV prevention efforts.

BACKGROUND: Youth in southern Africa, particularly adolescent girls and young women, are a key population for HIV prevention interventions. Untreated genital tract infections (GTIs) increase both HIV transmission and acquisition risks. South African GTI treatment guidelines employ syndromic management, which relies on individuals to report GTI signs and symptoms. Syndromic management may, however, underestimate cases, particularly among youth. We compared genital tract infection (GTI) prevalence by symptom-based and laboratory assessment among sexually-experienced youth in South Africa, overall and stratified by sex. METHODS: Interviewer-administered surveys assessed socio-demographics, behaviors, and GTI symptoms among 352 youth (16-24 yrs., HIV-negative or unknown HIV status at enrollment) enrolled in community-based cohorts in Durban and Soweto (2014-2016). Laboratory tests assessed HIV, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), Trichomonas vaginalis (TV) infections and, among females, bacterial vaginosis (BV) and Candida species. Youth with genital ulcers were tested for HSV-2 and syphilis. We assessed sensitivity (and specificity) of symptom-based reporting in identifying laboratory-confirmed GTIs. RESULTS: At baseline, 16.2% of females (32/198) and < 1% (1/154) of males reported ≥1 GTI symptom. However, laboratory tests identified ≥1 GTI in 70.2% and 10.4%, respectively. Female CT prevalence was 18.2%, NG 7.1%, MG 9.6%, TV 8.1%, and 5.1% were newly diagnosed with HIV. BV prevalence was 53.0% and candidiasis 9.6%. One female case of herpes was identified (0 syphilis). Male CT prevalence was 7.8%, NG 1.3%, MG 3.3%, TV < 1%, and 2.0% were newly diagnosed with HIV. Overall, 77.8% of females and 100% of males with laboratory-diagnosed GTIs reported no symptoms or were asymptomatic. Sensitivity (and specificity) of symptom-based reporting was 14% (97%) among females and 0% (99%) among males. CONCLUSION: A high prevalence of asymptomatic GTIs and very poor sensitivity of symptom-based reporting undermines the applicability of syndromic GTI management, thus compromising GTI control and HIV prevention efforts among youth. Syndromic GTI management does not meet the sexual health needs of young people. Policy changes incorporating innovations in GTI diagnostic testing are needed to reduce GTIs and HIV-associated risks among youth.

Provider understandings of and attitudes towards integration: Implementing an HIV and sexual and reproductive health service integration model, South Africa.

In South Africa, a lack of integration between sexual and reproductive health (SRH) and HIV services has led to lost opportunities in the treatment cascade. In a context of high HIV, tuberculosis (TB) and unplanned pregnancies, a model for integrating SRH and HIV services was implemented in a hospital and six feeder clinics in KwaZulu-Natal, South Africa. Changes in healthcare provider knowledge, attitudes and understandings were explored following model implementation. Baseline data were collected via focus group discussions (FGDs) and a cross-sectional survey, and were used to inform the development of a model for integrating SRH and HIV services. Following the implementation of the model, an endline survey was conducted to explore any changes. Four FGDs were conducted with healthcare providers at study facilities. A total of 46 providers participated in the baseline survey, and 44 in the endline survey. Qualitative data were thematically analysed using NVivo 11, and quantitative data were descriptively analysed using SPSS 24. The understanding of integration improved by endline. Integration of services was considered important for reducing stigma and increasing access to and improving quality of care. Concerns raised were that integration would increase workload and time per client. Physical structure of facilities was not always conducive to referral or integration. Perceived benefits of integration and actual integration of services improved between baseline and endline. Enhanced understanding of integration and increased levels of reported integration over time imply that providers are more aware, suggesting that the model was effective. Provider perspectives and understandings are important for the successful integration of services. This integration model is relevant and useful to inform training and mentoring of providers, as well as to provide recommendations for policy implementation.

Sexual and reproductive health services utilization by female sex workers is context-specific: results from a cross-sectional survey in India, Kenya, Mozambique and South Africa.

BACKGROUND: Female sex workers (FSWs) are extremely vulnerable to adverse sexual and reproductive health (SRH) outcomes. To mitigate these risks, they require access to services covering not only HIV prevention but also contraception, cervical cancer screening and sexual violence. To develop context-specific intervention packages to improve uptake, we identified gaps in service utilization in four different cities. METHODS: A cross-sectional survey was conducted, as part of the baseline assessment of an implementation research project. FWSs were recruited in Durban, South Africa (n = 400), Mombasa, Kenya (n = 400), Mysore, India (n = 458) and Tete, Mozambique (n = 308), using respondent-driven sampling (RDS) and starting with 8-16 'seeds' identified by the peer educators. FSWs responded to a standardised interviewer-administered questionnaire about the use of contraceptive methods and services for cervical cancer screening, sexual violence and unwanted pregnancies. RDS-adjusted proportions and surrounding 95% confidence intervals were estimated by non-parametric bootstrapping, and compared across cities using post-hoc pairwise comparison tests with Dunn-Sidák correction. RESULTS: Current use of any modern contraception ranged from 86.2% in Tete to 98.4% in Mombasa (p = 0.001), while non-barrier contraception (hormonal, IUD or sterilisation) varied from 33.4% in Durban to 85.1% in Mysore (p < 0.001). Ever having used emergency contraception ranged from 2.4% in Mysore to 38.1% in Mombasa (p < 0.001), ever having been screened for cervical cancer from 0.0% in Tete to 29.0% in Durban (p < 0.001), and having gone to a health facility for a termination of an unwanted pregnancy from 15.0% in Durban to 93.7% in Mysore (p < 0.001). Having sought medical care after forced sex varied from 34.4% in Mombasa to 51.9% in Mysore (p = 0.860). Many of the differences between cities remained statistically significant after adjusting for variations in FSWs' sociodemographic characteristics. CONCLUSION: The use of SRH commodities and services by FSWs is often low and is highly context-specific. Reasons for variation across cities need to be further explored. The differences are unlikely caused by differences in socio-demographic characteristics and more probably stem from differences in the availability and accessibility of SRH services. Intervention packages to improve use of contraceptives and SRH services should be tailored to the particular gaps in each city.

HIV prevention and care-seeking behaviour among female sex workers in four cities in India, Kenya, Mozambique and South Africa.

OBJECTIVE: To identify gaps in the use of HIV prevention and care services and commodities for female sex workers, we conducted a baseline cross-sectional survey in four cities, in the context of an implementation research project aiming to improve use of sexual and reproductive health services. METHODS: Using respondent-driven sampling, 400 sex workers were recruited in Durban, 308 in Tete, 400 in Mombasa and 458 in Mysore and interviewed face-to-face. RDS-adjusted proportions were estimated by nonparametric bootstrapping and compared across cities using post hoc pairwise comparison. RESULTS: Condom use with last client ranged from 88.3% to 96.8%, ever female condom use from 1.6% to 37.9%, HIV testing within the past 6 months from 40.5% to 70.9%, receiving HIV treatment and care from 35.5% to 92.7%, care seeking for last STI from 74.4% to 87.6% and having had at least 10 contacts with a peer educator in the past year from 5.7% to 98.1%. Many of the differences between cities remained statistically significant (P < 0.05) after adjusting for differences in FSWs' socio-demographic characteristics. CONCLUSION: The use of HIV prevention and care by FSWs is often insufficient and differed greatly between cities. Differences could not be explained by variations in socio-demographic sex worker characteristics. Models to improve use of condoms and HIV prevention and care services should be tailored to the specific context of each site. Programmes at each site must focus on improving availability and uptake of those services that are currently least used.

Barriers to HIV and sexual and reproductive health care for female sex workers in Tete, Mozambique: results from a cross-sectional survey and focus group discussions.

BACKGROUND: In the context of an operational research project in Tete, Mozambique, use of, and barriers to, HIV and sexual and reproductive health (HIV/SRH) commodities and services for female sex workers (FSWs) were assessed as part of a baseline situational analysis. METHODS: In a cross-sectional survey 311 FSWs were recruited using respondent driven sampling and interviewed face-to-face, and three focus group discussions were held with respectively 6 full-time Mozambican, 7 occasional Mozambican and 9 full-time Zimbabwean FSWs, to investigate use of, and barriers to, HIV/SRH care. RESULTS: The cross-sectional survey showed that 71 % of FSWs used non-barrier contraception, 78 % sought care for their last sexually transmitted infection episode, 51 % of HIV-negative FSWs was tested for HIV in the last 6 months, 83 % of HIV-positive FSWs were in HIV care, 55 % sought help at a health facility for their last unwanted pregnancy and 48 % after sexual assault, and none was ever screened for cervical cancer. Local public health facilities were by far the most common place where care was sought, followed by an NGO-operated clinic targeting FSWs, and places outside the Tete area. In the focus group discussions, FSWs expressed dissatisfaction with the public health services, as a result of being asked for bribes, being badly attended by some care providers, stigmatisation and breaches of confidentiality. The service most lacking was said to be termination of unwanted pregnancies. CONCLUSIONS: The use of most HIV and SRH services is insufficient in this FSW population. The public health sector is the main provider, but access is hampered by several barriers. The reach of a FSW-specific NGO clinic is limited. Access to, and use of, HIV and SRH services should be improved by reducing barriers at public health facilities, broadening the range of services and expanding the reach of the targeted NGO clinic.

Are HIV and reproductive health services adapted to the needs of female sex workers? Results of a policy and situational analysis in Tete, Mozambique.

BACKGROUND: In the context of an implementation research project aiming at improving use of HIV and sexual and reproductive health (SRH) services for female sex workers (FSWs), a broad situational analysis was conducted in Tete, Mozambique, assessing if services are adapted to the needs of FSWs. METHODS: Methods comprised (1) a policy analysis including a review of national guidelines and interviews with policy makers, and (2) health facility assessments at 6 public and 1 private health facilities, and 1 clinic specifically targeting FSWs, consisting of an audit checklist, interviews with 18 HIV/SRH care providers and interviews of 99 HIV/SRH care users. RESULTS: There exist national guidelines for most HIV/SRH care services, but none provides guidance for care adapted to the needs of high-risk women such as FSWs. The Ministry of Health recently initiated the process of establishing guidelines for attendance of key populations, including FSWs, at public health facilities. Policy makers have different views on the best approach for providing services to FSWs-integrated in the general health services or through parallel services for key populations-and there exists no national strategy. The most important provider of HIV/SRH services in the study area is the government. Most basic services are widely available, with the exception of certain family planning methods, cervical cancer screening, services for victims of sexual and gender-based violence, and termination of pregnancy (TOP). The public facilities face serious limitations in term of space, staff, equipment, regular supplies and adequate provider practices. A stand-alone clinic targeting key populations offers a limited range of services to the FSW population in part of the area. Private clinics offer only a few services, at commercial prices. CONCLUSION: There is a need to improve the availability of quality HIV/SRH services in general and to FSWs specifically, and to develop guidelines for care adapted to the needs of FSWs. Access for FSWs can be improved by either expanding the range of services and the coverage of the targeted clinic and/or by improving access to adapted care at the public health services and ensure a minimum standard of quality.

Effects of injectable contraception with depot medroxyprogesterone acetate or norethisterone enanthate on estradiol levels and menstrual, psychological and behavioral measures relevant to HIV risk: The WHICH randomized trial.

BACKGROUND: Observational data suggest lower HIV risk with norethisterone enanthate (NET-EN) than with depo-medroxyprogesterone acetate intramuscular (DMPA-IM) injectable contraceptives. If confirmed, a switch between these similar injectable methods would be programmatically feasible and could impact the trajectory of the HIV epidemic. We aimed in this paper to investigate the effects of DMPA-IM and NET-EN on estradiol levels, measures of depression and sexual activity and menstrual effects, relevant to HIV risk; and to ascertain whether these measures are associated with estradiol levels. METHODS: This open-label trial conducted at two sites in South Africa from 5 November 2018 to 30 November 2019, randomized HIV-negative women aged 18-40 to DMPA-IM 150 mg intramuscular 12-weekly (n = 262) or NET-EN 200 mg intramuscular 8-weekly (n = 259). Data were collected on hormonal, behavioral and menstrual effects at baseline and at 25 weeks (25W). RESULTS: At 25W, median 17ß estradiol levels were substantially lower than at baseline (p<0.001) for both methods: 76.5 pmol/L (interquartile range (IQR) 54.1 to 104.2) in the DMPA-IM group (n = 222), and 69.8 pmol/L (IQR: 55.1 to 89.3) in the NET-EN group (n = 225), with no statistical difference between the two methods (p = 0.450). Compared with DMPA-IM, NET-EN users reported significantly less amenorrhoea, fewer sexual acts, fewer users reporting at least one act of unprotected sex, more condom use with steady partner, more days with urge for sexual intercourse, more days feeling partner does not love her, and more days feeling sad for no reason. We did not find a clear association between estradiol levels and sexual behavior, depression and menstrual effects. Behavioral outcomes suggest less sexual exposure with NET-EN than DMPA-IM. The strength of this evidence is high due to the randomized study design and the consistency of results across the outcomes measured. CONCLUSIONS: Estradiol levels were reduced to postmenopausal levels by both methods. Secondary outcomes suggesting less sexual exposure with NET-EN are consistent with reported observational evidence of less HIV risk with NET-EN. A randomized trial powered for HIV acquisition is feasible and needed to answer this important question. TRIAL REGISTRATION: PACTR 202009758229976.