Sinead Delany-Moretlwe

Among South African women using oral HIV preexposure prophylaxis, we compared a urine tenofovir point-of-care test with dried blood spot tenofovir diphosphate concentrations for recent vs longer-term adherence and assessed acceptability. The test demonstrated 76% accuracy, 100% sensitivity, and 69% specificity for high adherence (tenofovir diphosphate ≥700 fmol/punch) and was highly acceptable. Clinical Trials Registration: NCT04038060.

Adolescent girls and young women (AGYW) at elevated HIV risk often experience common mental disorders (CMD), which are linked to lower PrEP adherence. We piloted a CMD intervention, the Youth Friendship Bench SA (YFB), and delivered alongside PrEP to improve CMD symptoms and PrEP adherence among South African AGYW. From April 2023-February 2024, 116 AGYW (18–25 years) with CMD symptoms were randomized to YFB plus standard of care (SOC) or SOC alone and followed for 12 weeks. In-depth interviews were conducted with 30 AGYW and 13 study staff and key informants. CMD screening alone was seen as beneficial, but referral uptake was low due to perceived severity thresholds, staff attitudes, and logistical barriers. YFB was highly acceptable to AGYW, who valued the intervention for being confidential, informal, and empowering. Integrated CMD and PrEP services were acceptable, and lay counsellor delivery shows promise for addressing the mental health care gap.

Background: Adolescent girls and young women (AGYW) in sub-Saharan Africa need HIV prevention options. Stigma may impede uptake and consistent use of oral pre-exposure prophylaxis (PrEP). We sought to understand how stigma manifested and influenced decisions of AGYW participating in a PrEP demonstration trial in Johannesburg, South Africa and Mwanza, Tanzania. Methods: This paper reports on serial qualitative in-depth interviews (IDI) with AGYW (n = 39) as well as healthcare providers and community stakeholders (n = 30) conducted during a randomized controlled trial that evaluated the effect of empowerment clubs to address harmful gender norms and stigma on PrEP persistence in AGYW aged 16–24 in South Africa and Tanzania. Analysis was thematic and inductive. Results: Stigma manifested in two main ways: HIV-related stigma and sexual behavior stigma. PrEP was often mistaken for antiretroviral therapy, and some participants taking daily PrEP reported that partners or family members thought they were living with HIV. Anticipated PrEP sexual stigma was common and linked with concerns around AGYW being perceived as promiscuous. While most participants anticipated stigma related to PrEP use, experiences of stigma were rare and did not deter AGYW from initiating PrEP. Many participants demonstrated resilience and remained confident in their decision to use PrEP and some developed strategies to avoid stigma, such as hiding pills or taking PrEP when partners or family members were not around. Conclusions: Our findings suggest that anticipated stigma is a common yet surmountable concern of AGYW initiating PrEP in eastern and southern Africa. Future PrEP implementation should be paired with multi-level activities to reduce stigma including empowerment activities for adolescents, strategies to reduce negative attitudes among health care providers and community-wide education to raise awareness and position PrEP as a responsible choice for young people to protect their health. Trial registration: Pan African Clinical Trials Registry PACTR202006754762723.

Primary prevention of HPV through vaccination of girls is central to effective control of cervical cancer and to achieving the new global goal of elimination. In South Africa’s school-based national HPV vaccination programme, coverage of both one and two doses of the bivalent vaccine has declined since its inception in 2014. Qualitative data on vaccine-decision making and vaccine hesitancy were collected alongside a study on the impact of a single-dose HPV vaccination schedule in one district of the Free State province, South Africa. Individual in-depth interviews were held with vaccine-eligible girls aged ≥15 years and their caregivers. In-depth key informant (KI) interviews were held with teachers, health and education ministry officials, and nurses who implemented the single-dose campaign. Twenty-one participants were interviewed, including six caregivers, six learners (one not vaccinated), and nine KIs. Caregivers consulted widely in vaccine decision-making, often with healthcare workers (HCW), and many sourced vaccine information on the internet. Learners frequently sought to convince their caregivers of the merits of vaccination. Fear of cancer was a strong motivator for vaccine acceptance, while vaccine hesitancy was mainly driven by fears of the vaccine causing serious side effects, infertility, or cancer. Learners queried the vaccine’s impact on their sexual and reproductive health (SRH) and black caregivers voiced suspicion of a racial bias in campaign targeting. Non-return of informed consent forms may reflect both administrative errors and potential vaccine refusal. The study highlights the need for HPV vaccine hesitancy in this setting to be explicitly addressed in future sensitization and advocacy activities.

The Southern African Journal of HIV Medicine is focused on HIV/AIDS treatment, prevention and related topics relevant to clinical and public health practice. The purpose of the journal is to disseminate original research results and support high-level learning related to HIV Medicine. It publishes original research articles, editorials, case reports/case series, reviews of state-of-the-art clinical practice and correspondence.

Background: HIV pre-exposure prophylaxis (PrEP) programmes in Africa reach young women at risk of sexually transmitted infections (STIs). We evaluated curable STI prevalence, incidence and risk factors among women initiating PrEP. Methods: From August to December 2022, sexually active women aged 16–30 years from 15 South African sites, and one site each in Eswatini, Kenya, Malawi, Uganda and Zambia were enrolled into the INSIGHT cohort and offered oral emtricitabine/tenofovir PrEP with follow-up at 1, 3 and 6 months. At each visit, STI symptoms were assessed and treatment provided based on syndromic management or diagnostic testing. Diagnostic tests included nucleic acid amplification for Chlamydia trachomatis and Neisseria gonorrhoeae , the rapid OSOM for Trichomonas vaginalis at enrolment and month 6, and serological testing for syphilis at enrolment using rapid plasma reagin with confirmatory Treponema pallidum particle agglutination. Prevalence and incidence of each STI were calculated, and predictors assessed using multivariable regression. Results: Of 3087 participants offered daily oral PrEP with a median age of 23 (IQR 21–27), 3011 had STI results and 30.9% had one or more STIs, with 15.7% reporting symptoms. The prevalence of C. trachomatis , N. gonorrhoeae , T. vaginalis and syphilis was 20.8%, 6.8%, 6.0% and 4.4%, respectively. The incidence of one or more STIs ( C. trachomatis , N. gonorrhoeae or T. vaginalis ) was 49.3/100 person-years (95% CI 45.3 to 53.4) with 12.7% reporting symptoms. The incidence of C. trachomatis was 30.6/100 person-years (95% CI 27.5 to 33.7), N. gonorrhoeae 10.8/100 person-years (95% CI 9.0 to 12.6) and T. vaginalis 11.5/100 person-years (95% CI 9.7 to 13.4). An incident STI diagnosis was associated with low alcohol use (adjusted incidence rate ratio (aIRR) 1.3; 95% CI 1.0 to 1.6) and moderate alcohol use (aIRR 1.4; 95% CI 1.1 to 1.8), and having an STI diagnosed at enrolment (aIRR 1.8; 95% CI 1.5 to 2.1). Conclusion: The high prevalence and incidence of STIs among African women initiating PrEP, most of whom did not report symptoms, highlights the need for aetiologic testing to detect STIs, guide treatment and reduce reproductive health sequelae and risk of transmission. Trial registration number: clinicaltrials.gov NCT05746065 .

Background: Achieving cervical cancer (CC) elimination requires addressing disparities in CC burden for women living with HIV (WLHIV) and how disparities evolve in the context of antiretroviral therapy (ART) scale-up. To inform CC elimination for high HIV prevalence regions, we modeled the impact of HIV, HIV interventions, and CC interventions in KwaZulu-Natal, South Africa. Methods: We used 2 independently developed, dynamic compartmental transmission models of HIV and human papillomavirus (DRIVE and Policy1-Cervix-HIV) calibrated to KwaZulu-Natal. We simulated: a counterfactual without HIV but with observed CC screening and vaccination; and scenarios sequentially adding condom use and voluntary medical male circumcision (VMMC); HIV; observed HIV and CC interventions (status quo); achieving United Nations Programme on HIV/AIDS HIV treatment targets; and achieving World Health Organization (WHO) CC elimination targets. The impact of each scenario was measured as the difference in CC incidence from the previous scenario. Results were reported from 2024 to 2124 as a range between the 2 models; CC elimination was WHO-defined as incidence <4/100 000 women-years. Results: For the status quo, CC incidence ranged from 61.30 to 78.96/100 000 women-years in 2024, with the highest incidence among WLHIV (126.8-192.0/100 000). HIV contributed an estimated 29.08-48.87 additional cases per 100 000. Neither model predicted elimination under status quo interventions, but achieving HIV treatment and CC elimination targets could reduce incidence to 1.42-6.25/100 000 women-years in 2124. Conclusions: HIV is associated with a population-level increase in CC incidence. However, scaling up ART coverage and CC interventions is expected to significantly reduce the burden of CC overall and among WLHIV. These conclusions are consistent between both models and strengthened by the comparative modeling approach.

Adolescent girls and young women (AGYW) in southern Africa face a high risk of HIV acquisition. Consistent use of daily oral pre-exposure prophylaxis (PrEP) can significantly mitigate this risk. We used the Good Participatory Practice Framework (GPP) to summarize lessons learned from engaging AGYW in an open-label PrEP trial, highlighting successful strategies that enhanced trial engagement. The HIV Prevention Trials Network (HPTN) 082 was an open-label study conducted from 2016 to 2018 that evaluated PrEP uptake and adherence in AGYW 16- to 25-year-old without HIV living in Cape Town and Johannesburg, South Africa, and Harare, Zimbabwe. Overall, 646 AGYW were screened for eligibility and 416 were enrolled. Fieldwork reflections, meeting summaries, Community Advisory Board (CAB) meeting minutes, and other project records were analyzed to synthesize lessons for stakeholder engagement relevant to PrEP introduction and service delivery. Using the GPP framework, several key lessons were identified. Early and comprehensive engagement with a broad range of stakeholders throughout the trial was crucial. Youth stakeholders played a significant role in shaping communication materials, clinic design, the package of HIV and non-HIV care, and referral pathways for supportive services. Identifying myths and misconceptions during early stakeholder engagements allowed for tailored PrEP education materials and approaches for PrEP-naïve communities. Parents and caregivers emerged as an essential group to engage to ensure support, even when adolescents were of legal age to provide consent. Peers were identified as important sources of information, support and referral for screening during the trial. Innovations to enhance engagement and results dissemination included the development of youth-led videos and peer support clubs. Introducing daily oral PrEP for young African AGYW required multiple strategies that were culturally sensitive, age-appropriate, and inclusive of peers, partners, parents, and other influential adults. These strategies were essential for fostering a supportive environment for PrEP use and enhancing engagement in the trial. Lessons learned from PrEP introduction to AGYW in southern Africa have relevance for future trials and HIV prevention programs. ClinicalTrials.gov NCT02732730, 13 November 2018.

Introduction: HPTN 084 found that long‐acting cabotegravir (CAB‐LA) was well‐tolerated and significantly reduced the risk of HIV acquisition in women compared to tenofovir disoproxil fumarate/emtricitabine (F/TDF). During the blinded phase of the trial, participants were required to use an effective method of contraception, including an injectable or implantable hormonal contraceptive (HC) agent. A contraceptive sub‐study assessed the pharmacokinetic interactions between pre‐exposure prophylaxis agents (CAB‐LA or F/TDF) and etonogestrel (ENG), medroxyprogesterone acetate (MPA) or norethindrone enanthate (NET‐EN). Methods: Participants were enrolled in a nested sub‐study between 24 February 2020 and 26 October 2020. Via a convenience sampling strategy, plasma concentrations of ENG, MPA and NET‐EN were evaluated at enrolment and weeks 25, 49 and 73; plasma tenofovir (TFV) and CAB concentrations were determined at contemporaneous visits. Participants were allowed to switch contraceptives, and HC assessments were adjusted accordingly. Geometric mean concentrations were calculated and compared using t ‐tests or Fisher's exact tests. Results: One hundred and seventy participants were included in this analysis. Hormone concentrations at all study visits were comparable between the CAB‐LA and F/TDF study arms. Among participants randomized to the CAB‐LA arm, geometric mean concentrations declined from enrolment to the follow‐up period for ENG (335 to 202 pg/ml), MPA (1520 to 1138 pg/ml) and NET‐EN (3715 to 1888 pg/ml); similar findings were observed among participants randomized to the F/TDF arm. Observed HC declines are likely attributed to the timing of contraceptive administration relative to sampling; the percentage of participants with hormone concentrations above thresholds associated with ovulation suppression was high (73−100%) and did not differ between arms. CAB concentrations were comparable across contraceptive types, with 97.8−98.1% of participants yielding trough CAB concentrations above the protocol‐specified target threshold. TFV concentrations were unquantifiable for most participants, irrespective of contraceptive agent, rendering comparisons largely uninformative. Conclusions: Given the comparable hormone concentrations between arms and the likely influence of the timing of sample collection on observed measurements, clinically significant interactions between CAB‐LA and HC are not expected. Associations between F/TDF and hormone concentrations could not be effectively evaluated due to low adherence to F/TDF. Clinical Trial Registration: NCT0316456