In-home TB Testing Using GeneXpert Edge is Acceptable, Feasible, and Improves the Proportion of Symptomatic Household Contacts Tested for TB: A Proof-of-Concept Study.

Background: Household contact investigations are effective for finding tuberculosis (TB) cases but are hindered by low referral uptake for clinic-based evaluation and testing. We assessed the acceptability and feasibility of in-home testing of household contacts (HHC) using the GeneXpert Edge platform. Methods: We conducted a 2-arm, randomized study in Eastern Cape, South Africa. HHCs were verbally assessed using the World Health Organization-recommended 4-symptom screen. Households with ≥1 eligible symptomatic contact were randomized. Intervention households received in-home GeneXpert MTB/RIF molecular testing. GeneXpert-positive HHCs were referred for clinic-based treatment. Standard-of-care households were referred for clinic-based sputum collection and testing. We defined acceptability as agreeing to in-home testing and feasibility as generation of valid Xpert MTB/RIF results. The proportion and timeliness of test results received was compared between groups. Results: Eighty-four households were randomized (n = 42 per arm). Of 100 eligible HHCs identified, 98/100 (98%) provided consent. Of 51 HHCs allocated to the intervention arm, all accepted in-home testing; of those, 24/51 (47%) were sputum productive and 23/24 (96%) received their test results. Of 47 HCCs allocated to standard-of-care, 7 (15%) presented for clinic-based TB evaluation, 6/47 (13%) were tested, and 4/6 (67%) returned for their results. The median (interquartile range) number of days from screening to receiving test results was 0 (0) and 16.5 (11-15) in the intervention and standard-of-care arms, respectively. Conclusions: In-home testing for TB was acceptable, feasible, and increased HHCs with a molecular test result. In-home testing mitigates a major limitation of household contact investigations (dependency on clinic-based referral), revealing new strategies for enhancing early case detection.

Youth-friendly services was the magic: Experiences of adolescent girls and young women in the community PrEP study, South Africa.

Adherence to daily oral pre-exposure prophylaxis (PrEP) for HIV prevention has been challenging for adolescent girls and young women (AGYW). As part of The Community PrEP Study (CPS), AGYW were randomised to HIV-prevention empowerment counselling (intervention) or basic medication pick-up (control). In this qualitative sub-study, we interviewed AGYW participants (n = 39) to explore PrEP use and study experiences by study arm, and study staff (n = 7) to explore study implementation, site environment, and participant engagement. Data were thematically analysed using a constant comparison approach. Comparative matrices assessed similarities and differences in study experiences and PrEP support preferences. Friendly, non-judgmental, non-stigmatizing study staff were described as central to participant's positive experiences. Participants highly valued CPS staff's holistic health support (e.g. physical and psycho-social). Intervention participants described empowerment counselling as helpful in supporting PrEP disclosure. However, control participants also described disclosing PrEP use to trusted individuals. Participants and staff recommended public-sector PrEP services provide holistic, confidential, and integrated sexual and reproductive health services, and community sensitisation. An adolescent and youth-friendly environment was the primary factor motivating AGYW's study engagement. While HIV-prevention empowerment counselling was well received, welcoming, respectful and non-judgmental staff may be the 'secret sauce' for implementing effective PrEP services to AGYW.

Validation of a brief screener for broad-spectrum mental and substance-use disorders in South Africa.

In low-resource settings, valid mental health screening tools for non-specialists can be used to identify patients with psychiatric disorders in need of critical mental health care. The Mental Wellness Tool-13 (mwTool-13) is a 13-item screener for identifying adults at risk for common mental disorders (CMDs) alcohol-use disorders (AUDs), substance-use disorders (SUD), severe mental disorders (SMDs), and suicide risk (SR). The mwTool-13 is administered in two steps, specifically, only those who endorse any of the initial three questions receive the remaining ten questions. We evaluated the performance of mwTool-13 in South Africa against a diagnostic gold standard. We recruited a targeted, gender-balanced sample of adults, aged ≥18 years at primary and tertiary healthcare facilities in Eastern Cape Province. Of the 1885 participants, the prevalence of CMD, AUD, SMD, SR, and SUD was 24.4%, 9.5%, 8.1%, 6.0%, and 1.6%, respectively. The mwTool-13 yielded high sensitivities for CMD, SMD, and SR, but sub-optimal sensitivities for AUD and SUD (56.7% and 64.5%, respectively). Including a single AUD question in the initial question set improved the tool's performance in identifying AUD and SUD (sensitivity > 70%), while maintaining brevity, face-validity, and simplicity in the South African setting.

High study participation but diverging adherence levels: qualitatively unpacking PrEP use among adolescent girls and young women over two years in Eastern Cape, South Africa.

In Southern and Eastern Africa, initiation of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention has been high among adolescent girls and young women (AGYW) offered PrEP. However, persistence and prevention-effective use of PrEP among this critical group continues to be a challenge. We conducted a qualitative sub-study of AGYW from the Community PrEP Study in Eastern Cape Province, South Africa who had high rates of pick up for monthly PrEP refills over two years, but differing levels of PrEP adherence based on tenofovir-diphosphate (TFV-DP) measurements in dried blood spots (DBS). Contrasting 22 AGYW with low versus high levels of TFV-DP in DBS, we qualitatively explored factors which influenced PrEP persistence vs. non-persistence, unique patterns of PrEP use (e.g., discarding or stockpiling), and participant recommendations for improving AGYW prevention-effective use of PrEP in the future. Results showed that PrEP misconceptions and mistrust among participants' social networks negatively influenced adherence. In comparison, supportive families and/or partners and personal trust that PrEP works positively influenced adherence. Those with low adherence described being motivated to come to the site for other study benefits (e.g., reimbursement money, snacks, sanitary pads) and discarding PrEP to avoid stigma associated with being seen with pills. Future PrEP implementation strategies should focus on involving families and partners in PrEP support for AGYW and minimizing PrEP stigma at a community level.Trial registration NCT03977181. Retrospectively registered on June 6, 2019.

Improving HIV testing, linkage, and retention in care among South African men through U=U messaging: A study protocol for two sequential hybrid type 1 effectiveness- implementation randomized controlled trials.

BACKGROUND: Increasing HIV testing and treatment coverage among people living with HIV (PLHIV) is essential for achieving global AIDS epidemic control. However, compared to women, cis-gender heterosexual men living with HIV are significantly less likely to know their HIV status, initiate anti-retroviral therapy (ART) and achieve viral suppression. This is particularly true in South Africa, where men are also at increased risk of mortality resulting from AIDS-related illnesses. While there is growing knowledge of Treatment as Prevention or the concept Undetectable=Untransmittable (U=U) among PLHIV in Western and high-income countries, the reach and penetration of the U=U message in sub-Saharan Africa remains limited, and few studies have evaluated the impact of accessible and relatable U=U messages on ART initiation and adherence. To address these gaps, rigorous evaluations of interventions that incorporate U=U messages are needed, especially among men in high prevalence settings. METHODS: Building on our U=U messages that we previously developed for men using behavioral economics insights and a human-centered design, we will conduct two sequential hybrid type 1 effectiveness-implementation trials to evaluate the impact of U=U messages on men's uptake of community-based HIV testing and ART initiation (Trial 1), and retention in care and achievement of viral suppression (Trial 2). A cluster randomized trial will be implemented for Trial 1, with HIV testing service site-days randomized to U=U or standard-of-care (SoC) messages inviting men to test for HIV. An individual-level randomized control trial will be implemented for Trial 2, with men initiating ART at six government clinics randomized to receive U=U counselling or SoC treatment adherence messaging. We will incorporate a multi-method evaluation to inform future implementation of U=U messaging interventions. The study will be conducted in the Buffalo City Metro Health District of the Eastern Cape Province and in the Cape Town Metro Health District in the Western Cape Province in South Africa. DISCUSSION: These trials are the first to rigorously evaluate the impact of U=U messaging on HIV testing uptake, ART initiation and achievement of viral suppression among African men. If effective, these messaging interventions can shape global HIV testing, treatment and adherence counselling guidelines and practices.

Developing the Speaking Out and Allying Relationships Intervention on Videoconference for HIV-Positive GBMSM in Eastern Cape, South Africa.

In South Africa, HIV prevalence for gay, bisexual, and men who have sex with men (GBMSM) is as high as 49.5%, yet only 25.7% are taking treatment, resulting in transmission risk between partners and the need for dyadic interventions for men in relationships. Through our preliminary research, we identified the evidence-based intervention Healthy Relationships (HR)-an HIV risk assessment and status disclosure intervention for those in relationships-to be tailored into videoconference format for partnered HIV-positive GBMSM in South Africa. The HR adaptation, called SOAR (Speaking Out & Allying Relationships), applied a human-centered design approach. In-depth interviews were conducted with HIV-positive GBMSM (N = 15) to refine intervention preferences with results used to establish a beta SOAR. A trained interventionist conducted SOAR functionality (n = 6) and usability (n = 7) tests with separate invited groups composed of the original participants interviewed. Field logs, focus group discussions, and a study-specific preference survey were administered. Thematic analysis and descriptive statistics were completed with a convergent analytical approach used to understand usability. Overall experience of GBMSM in SOAR was good (69%) or excellent (31%). More than half of the participants (61%) rated using videoconferencing for SOAR as good, with 38% rating it as fair. All participants stated that SOAR was understandable and satisfactory with willingness to recommend it to other GBMSM. This adaptation approach was effective, and the resultant SOAR intervention has the potential to improve individual coping and HIV communication skills with partners to engage with biomedical prevention and in turn support GBMSM couples.

Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa.

INTRODUCTION: Adolescent girls and young women (AGYW) face barriers that jeopardize their prevention-effective use of daily oral pre-exposure prophylaxis (PrEP). We sought to understand factors that influence AGYW's prolonged breaks in PrEP use, and their decisions to re-initiate or discontinue using PrEP in the context of a community-based adherence support intervention. METHODS: In-depth interviews (IDIs) were conducted between December 2019 and April 2021 with purposively selected AGYW (aged 16-25) enrolled in the Community PrEP Study (CPS) in Buffalo City Metro Health District, Eastern Cape Province, South Africa. AGYW were offered monthly PrEP for 24 months at two community-based study sites. Interview guides were informed by the Information-Motivation-Behavioural Skills Model, and data were analysed using illustrative code reports and a case analysis. RESULTS: A total of 603 participants were enrolled and initiated on PrEP in the parent study. Fifty-three IDIs were conducted with 50 CPS participants. Findings revealed that external factors (e.g. local movement, school holidays and medication side-effects) and social conflicts (e.g. discretion and partner mistrust) directly influenced breaks in PrEP usage. A decrease in one's self-perception of HIV risk prolonged the duration of these "PrEP breaks." Once PrEP refill visits were missed, some AGYW delayed returning for refills out of fear of being scolded by study staff. The differences between those participants who eventually re-initiated PrEP and those who disengaged from PrEP use can be attributed to social support and encouragement, level of familiarity with PrEP, risk perceptions, self-initiated discussions with staff and diminishing side effects. CONCLUSIONS: Despite implementing a community-based PrEP delivery platform and behavioural intervention that included support for daily oral PrEP adherence and disclosure, participants struggled with consistent daily oral PrEP use. Unpredictable life events, including local movement and schooling schedules, in addition to being judged for their perceived behaviours, pose a challenge for consistent pill pick-up for AGYW and habit formation. Long-acting injectable PrEP may mitigate a number of these external barriers. Interventions that integrate long-term planning skills, how to navigate existing social judgements and how to access sources of social support may further improve habit formation for PrEP use, regardless of its formulation.

What motivated men to start PrEP? A cross-section of men starting PrEP in Buffalo city municipality, South Africa.

BACKGROUND: Compared to women, South African men are less likely to know their HIV status (78% vs. 89%), have suppressed viral loads (82% vs. 90%), or access HIV prevention services. To achieve epidemic control where heterosexual sexual behavior drives transmission, interventions to improve the uptake of HIV testing services (HTS) and prevention services must also target cis-gendered, heterosexual men. There is limited understanding of these men's needs and wants with regards to accessing pre-exposure prophylaxis (PrEP). METHODS: Adult men (≥ 18 years) from a peri-urban community in Buffalo City Municipality were offered community-based HTS. Those who received a negative HIV test result were offered community-based, same-day oral PrEP initiation. Men initiating PrEP were invited to participate in a study exploring men's HIV prevention needs and reasons for initiating PrEP. An in-depth interview guide, developed using the Network-Individual-Resources model (NIRM), explored men's perceived HIV acquisition risk, prevention needs, and preferences for PrEP initiation. Interviews were conducted by a trained interviewer in isiXhosa or English, audio-recorded and transcribed. Thematic analysis was used, guided by the NIRM to generate findings. RESULTS: Twenty-two men (age range 18-57 years) initiated PrEP and consented to study participation. Men reported elevated HIV acquisition risk associated with alcohol use and condom-less sex with multiple partners as facilitators driving PrEP initiation. They anticipated social support from family members, their main sexual partner and close friends for their PrEP use, and discussed other men as important sources of support for PrEP initiation. Nearly all men expressed positive views of people using PrEP. Participants believed HIV testing would be a barrier for men interested in accessing PrEP. Men recommended that access to PrEP be convenient, rapid, and community-based (i.e., not clinic-based). DISCUSSION: Self-perceived risk for HIV acquisition was a major facilitator for men's PrEP initiation. Although men expressed positive perceptions of PrEP users, they noted that HIV testing may be a barrier to PrEP initiation. Finally, men recommended convenient access points to facilitate PrEP initiation and sustained use. Gender-responsive interventions tailored to men's needs, wants, and voices will facilitate their uptake of HIV prevention services, and help to end the HIV epidemic.

"I know why I am taking this pill": Young women navigation of disclosure and support for PrEP uptake and adherence in Eastern Cape Province, South Africa.

There is limited understanding of the dynamic interplay between adolescent girl's and young women's (AGYW) disclosure and social support for using oral pre-exposure prophylaxis (PrEP) and adherence. Towards this, we conducted interviews with 42 AGYW enrolled in The Community PrEP Study who exhibited either high or low blood concentrations of tenofovir-diphosphate (TFV-DP) in dried blood spots. Guided by Theories of Practice, interviews and analysis focused on AGYW perspectives and experiences with PrEP disclosure, support and adherence. AGYW with high TFV-DP blood concentrations described larger social support networks and disclosure events. In contrast, those with low TFV-DP blood concentrations described disclosing to fewer people, resulting in limited social support. Participants discussed partner support, however, this support was not described as consequential to adherence, irrespective of TFV-DP levels. Those with high levels of TFV-DP in their blood described the ability to navigate social scrutiny and changes in social support, while those with low levels of TFV-DP in their blood were more likely to question their own continued use of PrEP. To facilitate AGYW's prevention-effective use of PrEP, expanded skill-building for disclosure and resiliency against changes to social support should be examined as part of PrEP services.

Does It Matter What Screener We Use? A Comparison of Ultra-brief PHQ-4 and E-mwTool-3 Screeners for Anxiety and Depression Among People With and Without HIV.

The burden of depression and anxiety disorders is high in sub-Saharan Africa, especially for people with HIV (PWH). The Patient Health Questionnaire-4 (PHQ-4) and Electronic Mental Wellness Tool-3 (E-mwTool-3) are ultra-brief screening tools for these disorders. We compared the performance of PHQ-4 and E-mwTool-3 for screening MINI-International Neuropsychiatric Interview diagnoses of depression and anxiety among a sample of individuals with and without HIV in two primary care clinics and one general hospital in Maputo City, Mozambique. Areas-under-the-curve (AUC) were calculated along with sensitivities and specificities at a range of cutoffs. For PWH, at a sum score cutoff of ≥ 1, sensitivities were strong: PHQ-4:Depression = 0.843; PHQ-4:Anxiety = 0.786; E-mwTool-3:Depression = 0.843; E-mwTool-3:Anxiety = 0.929. E-mwTool-3 performance was comparable to PHQ-4 among people with and without HIV.

Qualitative Identification of Intervention Preferences to Support Men's Engagement and Retention in TB Care in South Africa.

Globally and in South African specifically, men account for 56% and 62% of all tuberculosis (TB) cases, respectively. Men are at increased risk of not accessing TB testing or treatment, and having poor treatment outcomes. Unfortunately, no interventions exist to address these issues. Toward the development of targeted, patient-centered TB care and support interventions, we used semistructured interviews to explored men's social network composition, TB testing behaviors, disclosure and treatment support, clinical experiences, and TB's influence on daily living. Data were analyzed using a thematic approach guided by the Network Individual Resource Model to identify mental and tangible resources influential and preferred during engagement in TB treatment. Men emphasized the desire for peer-to-peer support to navigate TB-related stigma and unhealthy masculinity norms. Men advocated for awareness events to educate communities about their challenges with TB. Men strongly suggested that interventions be delivered in familiar locations where men congregate. Since 2022, no TB treatment support interventions have included the preferred components or delivery modes described by men in our study. To improve men's TB-related health outcomes, the global TB community must identify and address men's unique challenges when designing interventions.

Acceptability and feasibility of leveraging community-based HIV counselling and testing platforms for same-day oral PrEP initiation among adolescent girls and young women in Eastern Cape, South Africa.

INTRODUCTION: Community-based delivery of HIV pre-exposure prophylaxis (PrEP) to South African adolescent girls and young women's (AGYW) could increase access but needs evaluation. We integrated PrEP services via home-based services and pop-up tents into existing community-based HIV testing services (CB-HTS) in Eastern Cape Province, South Africa. METHODS: After accessing CB-HTS via a "pop-up" tent or home-based services, HIV-negative AGYW aged 16-25 years were invited to complete a baseline questionnaire and referred for PrEP services at a community-based PrEP site co-located with pop-up HTS tents. A 30-day supply of PrEP was dispensed. PrEP uptake, time-to-initiation, cohort characteristics and first medication refill within 90 days were measured using descriptive statistics. RESULTS: Of the 1164 AGYW who tested for HIV, 825 (74.3%) completed a questionnaire and 806 (97.7%) were referred for community-based PrEP. Of those, 624 (77.4%) presented for PrEP (482/483 [99.8%] from pop-up HTS and 142/323 [44.0%] from home-based HTS), of which 603 (96.6%) initiated PrEP. Of those initiating PrEP following home-based HTS, 59.1% initiated within 0-3 days, 25.6% within 4-14 days and 15.3% took ≥15 days to initiate; 100% of AGYW who used pop-up HTS initiated PrEP the same day. Among AGWY initiating PrEP, 37.5% had a detectable sexually transmitted infection (STI). Although AGYW reported a low self-perception of HIV risk, post-hoc application of HIV risk assessment measures to available data classified most study participants as high risk for HIV acquisition. Cumulatively, 329 (54.6%) AGYW presented for a first medication refill within 90 days of accepting their first bottle of PrEP. CONCLUSIONS: Leveraging CB-HTS platforms to provide same-day PrEP initiation and refill services was acceptable to AGYW. A higher proportion of AGYW initiated PrEP when co-located with CB-HTS sites compared to those referred following home-based HTS, suggesting that proximity of CB-HTS and PrEP services facilitates PrEP uptake among AGYW. The high prevalence of STIs among those initiating PrEP necessitates the integration of STI and HIV prevention programs for AGYW. Eligibility for PrEP initiation should not be required among AHYW in high HIV burden communities. Community-based service delivery will be crucial to maintaining access to PrEP services during the COVID-19 pandemic and future health and humanitarian emergencies.

Factors influencing adolescent girls and young women's uptake of community-based PrEP services following home-based HIV testing in Eastern Cape, South Africa: a qualitative study.

Home-based service delivery has been used to improve access to HIV testing and antiretroviral initiation across sub-Saharan Africa, but it has yet to be leveraged to improve pre-exposure prophylaxis (PrEP) uptake. We interviewed 37 adolescent girls and young women (AGYW) in Eastern Cape, South Africa to explore why they chose to initiate PrEP or not following home-based HIV testing and referral for PrEP, and what influenced time to PrEP initiation. Participants reported that home visits provided a source of trusted information and a way to involve family members in their PrEP initiation decisions, motivating some to start PrEP. AGYW who initiated PrEP were more likely to qualitatively perceive themselves to be at high risk for HIV compared with those who never initiated PrEP. Integrating home-based HIV testing with PrEP education and referral may be a valuable way to reduce familial barriers and boost PrEP uptake among AGYW in South Africa. Trial registration: NCT03977181. Retrospectively registered on June 6, 2019.

Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial.

BACKGROUND: Sexually transmitted infections (STIs) during pregnancy are associated with adverse birth outcomes, including preterm birth, low birth weight, perinatal death, and congenital infections such as increased mother-to-child HIV transmission. Prevalence of STIs among pregnant women in South Africa remains high, with most women being asymptomatic for their infection(s). Unfortunately, most STIs remain undetected and untreated due to standard practice syndromic management in accordance with World Health Organization (WHO) guidelines. Although lab-based and point-of-care molecular tests are available, optimal screening strategies during pregnancy, their health impact, and cost-effectiveness are unknown. METHODS: We will implement a 3-arm (1:1:1) type-1 hybrid effectiveness-implementation randomized-controlled trial (RCT). We will enroll 2500 pregnant women attending their first antenatal care (ANC) visit for their current pregnancy at participating health facilities in Buffalo City Metro District, Eastern Cape Province, South Africa. Participants allocated to arms 1 and 2 (intervention) will receive GeneXpert® point-of-care diagnostic testing for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, with same-day treatment for detected infection(s). Arm 1 will additionally receive a test-of-cure 3 weeks post-treatment, while Arm 2 will receive a repeat test at 30-34 weeks' gestation. Those allocated to Arm 3 will receive syndromic management (standard-of-care). The RE-AIM framework will be used to guide collection of implementation indicators to inform potential future scale up. Primary outcome measures include (1) frequency of adverse birth outcomes among study arms, defined by a composite measure of low birth weight and pre-term delivery, and (2) change in STI prevalence between baseline and birth outcome among intervention arms and compared to standard-of-care. Estimates and comparative costs of the different screening strategies relative to standard-of-care and the costs of managing adverse birth outcomes will be calculated. Cost-effectiveness will be assessed per STI and disability-adjusted life year averted. DISCUSSION: This trial is the first RCT designed to identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes. Demonstrating the impact of diagnostic screening and treatment, compared to syndromic management, on birth outcomes will provide critical evidence to inform changes to WHO guidelines for syndromic management of STIs during pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04446611 . Registered on 25 June 2020.

A Skills-Based HIV Serostatus Disclosure Intervention for Sexual Minority Men in South Africa: Protocol for Intervention Adaptation and a Pilot Randomized Controlled Trial.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV have low antiretroviral treatment adherence in South Africa due to limited skills in managing disclosure and prevention behaviors with sexual and romantic partners. As a result, there is a high HIV transmission risk within HIV-discordant partnerships, but an existing intervention may address these outcomes, if adapted effectively. Healthy Relationships (HR) is a behavioral intervention that was originally delivered in groups and in person over 5 sessions to develop coping skills for managing HIV-related stress and sexually risky situations, enhance decision-making skills for HIV disclosure to partners, and establish and maintain safer sex practices with partners. HR effectively improves prevention behaviors but has yet to be tailored to a non-US context. OBJECTIVE: We aim to adapt HR into a new culturally grounded intervention entitled Speaking Out & Allying Relationships for GBMSM and then assess its feasibility in Eastern Cape, South Africa. METHODS: The study will have 2 aims. For aim 1-adaptation-we will use a human-centered design approach. Initial intervention tailoring will involve integrating Undetectable=Untransmittable and pre-exposure prophylaxis education, developing intervention content for a videoconference format, and designing role-plays and movies for skill building based on preliminary data. Afterward, interviews and surveys will be administered to GBMSM to assess intervention preferences, and a focus group will be conducted with health care providers and information technology experts to assess the intervention's design. Finally, a usability test will be performed to determine functionality and content understanding. Participants will be GBMSM living with HIV (n=15) who are in a relationship and health care providers and information technology (n=7) experts working in HIV care and programming with this population. For aim 2, we will examine the feasibility of the adapted intervention by using a pilot randomized control design. There will be 60 individuals per arm. Feasibility surveys and interviews will be conducted with the intervention arm, and behavioral and biomedical assessments for relationship and treatment adherence outcomes will be collected for both arms. All participants will be GBMSM living with HIV who are in a relationship with an HIV-negative or unknown status partner. RESULTS: Intervention adaptation began in August 2021. Initial tailoring and the refining of GBMSM intervention preferences were completed in December 2021. Usability and feasibility assessments are due to be completed by March 2022 and February 2024, respectively. CONCLUSIONS: GBMSM need efficacious interventions that tackle partnership dynamics, HIV prevention, and treatment outcomes for antiretroviral treatment adherence and viral suppression in South Africa. Harnessing everyday technology use for social networking (eg, videoconferences), Undetectable=Untransmittable education, and pre-exposure prophylaxis to update an existing intervention for South African GBMSM has the potential to strengthen relationship communication about HIV treatment and prevention and, in turn, improve outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36845.

Impact of aetiological screening of sexually transmitted infections during pregnancy on pregnancy outcomes in South Africa.

BACKGROUND: Sexually transmitted infections (STIs) during pregnancy may increase the risk of adverse pregnancy outcomes. STI syndromic management is standard of care in South Africa but has its limitations. We evaluated the impact of diagnosing and treating curable STIs during pregnancy on adverse pregnancy and birth outcomes. METHODS: We combined data from two prospective studies of pregnant women attending public sector antenatal care (ANC) clinics in Tshwane District and Cape Town, South Africa. Pregnant women were enrolled, tested and treated for STIs. We evaluated the association between any STI at the first ANC visit and a composite adverse pregnancy outcome (miscarriage, stillbirth, preterm birth, early neonatal death, or low birthweight) using modified Poisson regression models, stratifying by HIV infection and adjusting for maternal characteristics. RESULTS: Among 619 women, 61% (n = 380) were from Tshwane District and 39% (n = 239) from Cape Town; 79% (n = 486) were women living with HIV. The prevalence of any STI was 37% (n = 228); C. trachomatis, 26% (n = 158), T. vaginalis, 18% (n = 120) and N. gonorrhoeae, 6% (n = 40). There were 93% (n = 574) singleton live births, 5% (n = 29) miscarriages and 2% (n = 16) stillbirths. Among the live births, there were 1% (n = 3) neonatal deaths, 7% (n = 35) low birthweight in full-term babies and 10% (n = 62) preterm delivery. There were 24% (n = 146) for the composite adverse pregnancy outcome. Overall, any STI diagnosis and treatment at first ANC visit was not associated with adverse outcomes in women living with HIV (adjusted relative risk (aRR); 1.43, 95% CI: 0.95-2.16) or women without HIV (aRR; 2.11, 95% CI: 0.89-5.01). However, C. trachomatis (aRR; 1.57, 95% CI: 1.04-2.39) and N. gonorrhoeae (aRR; 1.69, 95% CI: 1.09-3.08), were each independently associated with the composite adverse outcome in women living with HIV. CONCLUSION: Treated STIs at the first ANC visit were not associated with adverse pregnancy outcome overall. In women living with HIV, C. trachomatis or N. gonorrhoeae at first ANC were each independently associated with adverse pregnancy outcome. Our results highlights complex interactions between the timing of STI detection and treatment, HIV infection and pregnancy outcomes, which warrants further investigation.