Browsing by Subject "PrEP"

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    Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa—study protocol for a mixed-methods study including a randomised controlled trial
    (2020-10-30) Nash, S; Dietrich, J; Ssemata, A S; Herrera, C; O’Hagan, K; Else, L; Chiodi, F; Kelly, C; Shattock, R; Chirenje, M; Lebina, L; Khoo, S; Bekker, L-G; Weiss, H A; Gray, C; Stranix-Chibanda, L.; Kaleebu, P; Seeley, J; Martinson, N; Fox, J
    Background HIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability and uptake. The cost of a non-inferiority phase III trial is likely to be prohibitive, and thus, it is essential to select the best possible drug, dose and schedule in advance. The aim of this study, the Combined HIV Adolescent PrEP and Prevention Study (CHAPS), is to investigate the drug, dose and schedule of pre-exposure prophylaxis (PrEP) required for the protection against HIV and the acceptability of PrEP amongst young people in sub-Saharan Africa, and hence to inform the choice of intervention for future phase III PrEP studies and to improve strategies for PrEP implementation. Methods We propose a mixed-methods study amongst young people aged 13–24 years. The first component consists of qualitative research to identify the barriers and motivators towards the uptake of PrEP amongst young people in South Africa, Uganda and Zimbabwe. The second component is a randomised clinical trial (ClinicalTrials.gov NCT03986970, June 2019) using a novel ex vivo HIV challenge method to investigate the optimal PrEP treatment (FTC-TDF vs FTC-TAF), dose and schedule. We will recruit 144 amongst HIV-negative uncircumcised men aged 13–24 years from voluntary male medical circumcision clinics in two sites (South Africa and Uganda) and randomise them into one of nine arms. One group will receive no PrEP prior to surgery; the other arms will receive either FTC-TDF or FTC-TAF, over 1 or 2 days, and with the final dose given either 6 or 20 h prior to surgery. We will conduct an ex vivo HIV challenge on their resected foreskin tissue. Discussion This study will provide both qualitative and quantitative results to help decide the optimum drug, dose and schedule for a future phase III trial of PrEP. The study will also provide crucial information on successful strategies for providing PrEP to young people in sub-Saharan Africa. Trial registration ClinicalTrials.gov NCT03986970 . Registered on 14 June 2019
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    The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol
    (2021-07-26) Medina-Marino, Andrew; Bezuidenhout, Dana; Hosek, Sybil; Barnabas, Ruanne V.; Atujuna, Millicent; Bezuidenhout, Charl; Ngwepe, Phuti; Peters, Remco P H; Little, Francesca; Celum, Connie L; Daniels, Joseph; Bekker, Linda-Gail
    Background HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers to clinic-based sexual and reproductive health services. Even when AGYW access PrEP as an HIV prevention method, poor prevention-effective use was a serious barrier to achieving its optimal HIV prevention benefits. Determining the acceptability and feasibility of community-based platforms to increase AGYW’s access to PrEP, and evaluating behavioural interventions to improve prevention-effective use of PrEP are needed. Methods We propose a mixed-methods study among AGYW aged 16–25 years in Eastern Cape Province, South Africa. In the first component, a cross-sectional study will assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to refer HIV-negative, at-risk AGYW to non-clinic-based, same-day PrEP initiation services. In the second component, we will enrol 480 AGYW initiating PrEP via our CBCT platforms into a three-armed (1:1:1) randomized control trial (RCT) that will evaluate the effectiveness of adherence support interventions to improve the prevention-effective use of PrEP. Adherence will be measured over 24 months via tenofovir-diphosphate blood concentration levels. Qualitative investigations will explore participant, staff, and community experiences associated with community-based PrEP services, adherence support activities, study implementation, and community awareness. Costs and scalability of service platforms and interventions will be evaluated. Discussion This will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW. Trial registration ClinicalTrials.gov NCT03977181 . Registered on 6 June 2019—retrospectively registered.
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    Gendered lives, constrained choice and young African women's PrEP uptake and persistent use as a gender-responsive approach to HIV prevention
    (2024) Rousseau, Elzette; Bekker, Linda-Gail; Sikkema, Kathleen
    While there is substantial momentum to scale up PrEP (pre-exposure prophylaxis) for HIV prevention in adolescent girls and young women (AGYW), this population is demonstrating difficulty in sustained PrEP use. PrEP use at the time of HIV exposure is critical for effectiveness. This thesis investigated AGYW's decision-making throughout the PrEP-user journey (from PrEP uptake to persistence or discontinuation). It reflected on the role of agency (personal and relational), gender, and PrEP access and how these facilitated or constrained PrEP use. The research used a multi-method approach, including pharmacy record review, in-depth interviews, and structured surveys. This cohort included 2550 AGYW participants (aged 16-25 years) of the POWER implementation study receiving oral PrEP for up to 36 months in Cape Town and Johannesburg, South Africa, and Kisumu, Kenya. The POWER study was designed to develop and evaluate scalable models of PrEP delivery. Across analyses, PrEP uptake facilitators included PrEP integration with sexual and reproductive health services but were hampered by PrEP misconceptions and stigma in the community. Disclosure, social support, adolescent-friendly counselling, and convenient access were key enablers for PrEP persistence. Beyond this, AGYW were influenced by intrinsic (strong self-determination and autonomy finding PrEP adherence personally fulfilling) and extrinsic motivations (where PrEP use habits are influenced by external factors or rewards, social pressure, or fear of negative relational consequences). The research showed that AGYW's diversity in needs, habits, and lifestyles also influenced their PrEP access preferences, which led to the segmentation of this group into convenient, independent, social, or discreet PrEP users for optimised tailored service delivery. While the role of sexual relationship power in AGYW's PrEP continuation was also investigated, no significant influence was observed. In conclusion, the findings suggest that AGYW are empowered to make positive PrEP use decisions when their agency is ignited and/or when AGYW are presented with access alternatives to choose from (differentiated models of PrEP delivery). AGYW's agency fluctuated in contexts of community stigma, non-disclosure, harmful relationship dynamics, and emotional arousal; however, differentiated PrEP access created alternatives (a potential buffer zone) for these instances of limited agency.
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    Oral PrEP use among pregnant or parenting young women in South Africa: evidence from a large community-based implementation study
    (2026) Chen-Charles, Jenny Davey, Dvora J. Rousseau, Elzette Little, Francesca Toska, Elona Mathola, Ntombovuyo Macdonald, Pippa Vanto, Onesimo Wallace, Melissa Bekker, Linda-Gail; Davey, Dvora J; Rousseau, Elzette; Little, Francesca; Toska, Elona; Mathola, Ntombovuyo; Macdonald, Pippa; Vanto, Onesimo; Wallace, Melissa; Bekker, Linda-Gail, Melissa
    Abstract Background The risk of HIV acquisition is heightened during pregnancy and early parenthood with the additional risk of vertical HIV transmission. While recent studies have improved our understanding of PrEP use among pregnant and breastfeeding women, further evidence is needed to inform the design of interventions that support sustained use, especially among young women who are pregnant or parenting. Methods We analysed data from young women aged 15–29 years who initiated PrEP in an implementation study (FastPrEP) in Cape Town, South Africa. Logistic regression was used to examine the association between pregnancy or parenting status (≥ 1 living child) and PrEP discontinuation at 1- and 4-months post-initiation, based on pharmacy refill data. The primary exposure was currently pregnant or having a child (vs. not); secondary analyses stratified by age (15–24 vs. 25–29 years) among women who were pregnant/parenting. Models were adjusted for age and hypothesised explanatory factors were included in sensitivity analysis: service delivery location, contraceptive use, HIV risk perception, and relationship status. Results Between August 2022 and June 2024 n = 4,876 young women initiated PrEP; 44% were pregnant/parenting (of which 10% were pregnant), and the median age was 21.6 years (IQR:18–25). At 1-month, women who were pregnant/parenting had higher odds of PrEP discontinuation (aOR:1.30, 95% CI:1.14–1.49). At 4-months this relationship persisted (aOR:1.41, 95% CI:1.12–1.78) compared with non-pregnant/parenting women. Among those pregnant/parenting, younger women (15–24 years) had higher odds of discontinuation at 1-month (aOR:1.31, 95% CI:1.08–1.58) and 4-months (aOR:1.41, 95%CI:1.02–1.96) compared to women aged 25–29. In the fully adjusted multivariable model, receiving PrEP in mobile clinics (aOR:0.71, 95% CI:0.61–0.82) vs. government clinics was associated with lower odds of early discontinuation. Conclusion Young women who are pregnant/parenting face elevated risk of early PrEP discontinuation. Differentiated, life-stage and youth-responsive interventions, such as counselling, partner involvement, and integration with maternal and child health, or sexual and reproductive health services, are critical to improving PrEP persistence among this priority population. This population should be prioritised in the rollout of long-acting PrEP formulations, which may better align with their needs and reduce the burden of daily adherence.
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    Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial
    (2022-07-07) Joseph Davey, Dvora L.; Dovel, Kathryn; Cleary, Susan; Khadka, Nehaa; Mashele, Nyiko; Silliman, Miriam; Mvududu, Rufaro; Nyemba, Dorothy C.; Coates, Thomas J.; Myer, Landon
    Background HIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women’s engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use. Methods Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation. Discussion This study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting. Trial registration NCT05322629 : Date of registration: April 12, 2022.
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    Symptoms of post-traumatic stress and associations with sexual behaviour and PrEP preferences among young people in South Africa, Uganda and Zimbabwe
    (2022-05-16) Webb, Emily L; Dietrich, Janan J; Ssemata, Andrew S; Nematadzira, Teacler G; Hornschuh, Stefanie; Kakande, Ayoub; Tshabalala, Gugulethu; Muhumuza, Richard; Mutonyi, Gertrude; Atujuna, Millicent; Bere, Tarisai; Bekker, Linda-Gail; Abas, Melanie A; Weiss, Helen A; Seeley, Janet; Stranix-Chibanda, Lynda; Fox, Julie
    Background It is not known whether post-traumatic stress disorder (PTSD) increases HIV-risk behaviours among young people in sub-Saharan Africa. We assessed associations of PTSD symptoms with sexual behaviour, HIV risk perception, and attitudes towards PrEP among young people taking part in the CHAPS community survey. We hypothesised that PTSD symptoms would increase sexual behaviours associated with HIV risk, hinder PrEP uptake and influence preference for daily versus on-demand PrEP. Methods Young people without HIV, aged 13–24 years, were purposively recruited in Johannesburg and Cape Town in South Africa, Wakiso in Uganda, and Chitungwiza in Zimbabwe, and surveyed on socio-demographic characteristics, PrEP knowledge and attitudes, sexual behaviour, HIV perception and salience, and mental health. PTSD symptoms were measured using the Primary Care PTSD Screen for the Diagnostic and Statistical Manual of Mental Disorders 5 (PC-PTSD-5). Logistic and ordinal logistic regression was used to assess associations between PC-PTSD-5 score and socio-demographic characteristics, sexual behaviour, HIV risk perception, PrEP attitudes, and substance use, adjusting for age, sex, setting, depression and anxiety. Results Of 1330 young people (51% male, median age 19 years), 522 (39%) reported at least one PTSD symptom. There was strong evidence that having a higher PC-PTSD-5 score was associated with reported forced sex (OR 3.18, 95%CI: 2.05–4.93), self-perception as a person who takes risks (OR 1.12, 95%CI: 1.04–1.20), and increased frequency of thinking about risk of HIV acquisition (OR 1.16, 95%CI: 1.08–1.25). PTSD symptoms were not associated with willingness to take PrEP, preference for on-demand versus daily PrEP, or actual HIV risk behaviour such as condomless sex. Conclusions Symptoms consistent with probable PTSD were common among young people in South Africa, Uganda and Zimbabwe but did not impact PrEP attitudes or PrEP preferences. Evaluation for PTSD might form part of a general assessment in sexual and reproductive health services in these countries. More work is needed to understand the impact of PTSD on HIV-risk behaviour, forced sex and response to preventive strategies including PrEP.