Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Medina-Marino A

PROVIDER: S-EPMC8314507 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionCommunity-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.MethodsAfter 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.ResultsOf 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.ConclusionsLeveraging 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.

Project description:IntroductionAdolescent girls and young women (AGYW) are a priority population for pre-exposure prophylaxis (PrEP), a highly effective HIV prevention method. However, effective PrEP use among AGYW has been low. Interventions to support PrEP effective use may improve pill-taking. Affordability of PrEP programs depends on their cost. We, therefore, evaluated the cost of community-based PrEP with effective use counselling.MethodsCost data from a randomized controlled trial were used to evaluate the cost of PrEP provision with effective use counselling offered to AGYW through community-based HIV testing platforms between November 2018 and November 2019. AGYW were randomized to receive (1) group-based community health club effective use counselling, (2) individualized effective use counselling or (3) community-based PrEP dispensary. Task shifting of effective use counselling from nurses to trained lay counsellors was implemented in groups 1 and 2. Personnel costs were estimated from time-and-motion observations and staff interviews. Expenditure and ingredients-based approaches were used to estimate costs for medical and non-medical supplies.ResultsIn total, 603 AGYW initiated PrEP and accrued a total of 1280 months on PrEP. Average cost per person-month on PrEP with group-based community health club, individualized effective use counselling and community-based PrEP dispensary under the Department of Health scenario were similar and high (USD $55.32, $55.65 and $55.46, respectively) due to low PrEP client volume observed in the clinical trial. Increasing client volume (scaled Department of Health scenario) reduced cost per-person month estimates to USD $15.48, $26.40 and $13.99, respectively.ConclusionsAs designed, individualized effective use counselling increased the cost of standard-of-care PrEP delivery by 89%, group-based community health effective use counselling increased the cost of standard-of-care PrEP delivery by 11%. These estimates can inform cost-effectiveness and budget impact analysis for PrEP provision with effective use counselling services.

Project description:BackgroundPre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but disparities in PrEP access remain considerable, particularly among Black and Latino men who have sex with men (MSM). To address this, the University of Miami Mobile PrEP Program was created, offering mobile HIV prevention/PrEP services in areas throughout South Florida where HIV incidence is high and PrEP access is geographically limited. Using a community-centered participatory approach, the program strategized and executed expansion into the Liberty City neighborhood of Miami. This study qualitatively assessed factors affecting Mobile PrEP implementation as perceived by community stakeholders, clients, and program staff.MethodsForty-one in-depth interviews were conducted with 21 Mobile PrEP clients, 10 key informants from local health organizations, and 10 program staff. Interview questions queried perceived organizational and positional barriers and facilitators to mobile clinic implementation. Service satisfaction, setting preferences, social factors, and likelihood of recommending Mobile PrEP were also assessed. A thematic content analysis was performed using the Consolidated Framework for Implementation Research (CFIR) taxonomy as the guiding constructs for the analysis.ResultsParticipant statements indicated that providing no-cost services, convenient location, program-covered rideshares, individualized patient navigation, and a community-centric approach to patient care, which included staff members with shared lived experiences to increase positive interactions and renewed trust among poorly served communities, were facilitators of PrEP access and intervention uptake. The importance of program familiarization with the community before implementation, particularly for Black and African American communities, who may experience unique barriers to accessing sexual healthcare was strongly emphasized by participants.ConclusionsThe Mobile PrEP intervention was found to be an acceptable and accessible mode of HIV/STI preventive care. The importance of pre-implementation community engagement and preparation is emphasized. Future research is needed to refine understanding of the intervention's components and evaluate implementation determinants in other highly impacted neighborhoods.

Project description:IntroductionThere is limited understanding of how social dynamics impact pre-exposure prophylaxis (PrEP) adherence among adolescent girls and young women (AGYW) in generalized HIV-epidemic settings. We examined experiences of oral PrEP use disclosure to various social groups with the goal of identifying supportive relationships that can be leveraged to promote adherence.MethodsWe used qualitative methods to explore experiences disclosing PrEP use and the perceived impact of disclosure on adherence among 22 South African AGYW (16-25 years) taking daily oral PrEP. Serial in-depth-interviews (IDIs) were conducted 1-, 3-, and 12-months post-PrEP initiation. Respondents also self-reported their disclosures separately for various social groups and adherence was assessed using intracellular tenofovir-diphosphate levels.ResultsQualitative respondents had a median age of 20.5 years and reported disclosing their PrEP use to friends (n = 36 total disclosures), partners, siblings, other family members (n = 24 disclosures each), and parents (n = 19 disclosures). IDI data revealed that parents and partners provided the most support to respondents and a lack of support from these groups was most often perceived as negatively affecting PrEP use. AGYW described difficulties explaining PrEP to their mothers, who believed PrEP was HIV treatment or would lead to HIV infection. Disclosure to household members was notably meaningful for AGYW (both positively and negatively). Respondents reported leveraging supportive relationships for pill reminders. For respondents who perceived a household member would be unsupportive, however, non-disclosure was less feasible and PrEP use was often stigmatized. To avoid stigma, several respondents hid or discontinued PrEP.ConclusionsWhile supportive relationships may facilitate PrEP use, disclosure can also lead to stigma. Counselors should support AGYW in disclosing to key people in their social networks and provide AGYW with materials that lend credibility to explanations of PrEP. Community education is necessary to alleviate PrEP-related stigma and facilitate disclosure.

Project description:A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States.Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time.Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations.While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their practice.

Project description:BackgroundDaily doses of pre-exposure prophylaxis (PrEP) can reduce the risk of acquiring HIV by more than 95 %. In sub-Saharan Africa, adolescent girls and young women (AGYW) are at disproportionately high risk of acquiring HIV, accounting for 25 % of new infections. There are limited data available on implementation approaches to effectively reach and deliver PrEP to AGYW in high HIV burden communities.MethodsWe explored the feasibility and acceptability of providing PrEP to AGYW (aged 16-25 years) via a community-based mobile health clinic (CMHC) known as the Tutu Teen Truck (TTT) in Cape Town, South Africa. The TTT integrated PrEP delivery into its provision of comprehensive sexual and reproductive health services (SRHS). We analyzed data from community meetings and in-depth interviews with 30 AGYW PrEP users to understand the benefits and challenges of PrEP delivery in this context.ResultsA total of 585 young women started PrEP at the TTT between July 2017 - October 2019. During in-depth interviews a subset of 30 AGYW described the CMHC intervention for PrEP delivery as acceptable and accessible. The TTT provided services at times and in neighborhood locations where AGYW organically congregate, thus facilitating service access and generating peer demand for PrEP uptake. The community-based nature of the CMHC, in addition to its adolescent friendly health providers, fostered a trusting provider-community-client relationship and strengthened AGYW HIV prevention self-efficacy. The integration of PrEP and SRHS service delivery was highly valued by AGYW. While the TTT's integration in the community facilitated acceptability of the PrEP delivery model, challenges faced by the broader community (community riots, violence and severe weather conditions) also at times interrupted PrEP delivery.ConclusionsPrEP delivery from a CMHC is feasible and acceptable to young women in South Africa. However, to effectively scale-up PrEP it will be necessary to develop diverse PrEP delivery locations and modalities to meet AGYW HIV prevention needs.

Project description:IntroductionAdolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) demonstration projects observe that AGYW uptake and adherence to PrEP during risk periods is suboptimal. Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW. Improving HCW competency and communication to support PrEP delivery to AGYW requires new strategies.Methods and analysisPrEP Implementation for Young Women and Adolescents Program-standardised patient (PrIYA-SP) is a cluster randomised trial of a standardised patient actor (SP) training intervention designed to improve HCW adherence to PrEP guidelines and communication skills. We purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya. At baseline, unannounced SP 'mystery shoppers' present to clinics portraying AGYW in common PrEP scenarios for a cross-sectional assessment of PrEP delivery. Twelve facilities will be randomised to receive a 2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing. Unannounced SPs will repeat the assessment in all 24 sites following the intervention. The primary outcome is quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist by SPs blinded to intervention assignment. An intention-to-treat (ITT) analysis will evaluate whether the intervention resulted in higher scores within intervention compared with control facilities, adjusted for baseline SP scores and accounting for clustering by facility. We hypothesise that the intervention will improve quality of PrEP counselling compared with standard of care. Results from this study will inform guidelines for PrEP delivery to AGYW in low-resource settings and offer a potentially scalable strategy to improve service delivery for this high-risk group.Ethics and disseminationThe protocol was approved by institutional review boards at Kenyatta National Hospital and University of Washington. An external advisory committee monitors social harms. Results will be disseminated through peer-reviewed journals and presentations.Trial registration numberNCT03875950.

Project description:IntroductionOral pre-exposure prophylaxis (PrEP) is increasingly being implemented in sub-Saharan Africa. Adolescent girls and young women (AGYW) in Kenya contribute more than half of all new infections among young people aged 15-24 years, highlighting the need for evidence on the cost of PrEP in real-world implementation to inform the budget impact, cost-effectiveness, and financial sustainability of PrEP programs.MethodsWe estimated the cost of delivering PrEP to AGYW enrolled in a PrEP implementation study in two family planning clinics in Kisumu county, located in western Kenya. We derived total annual costs and the average cost per client-month of PrEP by input type (variable or fixed) and visit type (initiation or follow-up). We estimated all costs as implemented in the study, and under implementation by the Kenyan Ministry of Health (MoH), both at the program volume observed and if the facilities were delivering PrEP at full capacity (scaled-MoH).ResultsFor the costing period between March 2018 and March 2019, 615 HIV-negative women contributed 1,128 (502 initiation and 626 follow-up) visits. The average cost per client-month of PrEP dispensed per study protocol and per the MoH scenario was $28.92 and $14.52, respectively. If the MoH scaled the program so that facilities could see PrEP clients at capacity, the average cost per client-month of PrEP was $10.88. Medication costs accounted for the largest proportion of the total annual costs (48% in MoH scenario and 65% in the scaled-MoH scenario).ConclusionsUsing data from a PrEP implementation program, we found that the cost per client-month of PrEP dispensed is reduced by 62% if PrEP delivery at the two clinics is scaled up by the MoH. Our findings are valuable for informing local resource allocation and budgetary cost projections for scale-up of PrEP delivery to AGYW. Additionally, previous cost-effectiveness studies have been limited by the use of fixed assumptions of the cost of PrEP per person-month. Our study provides cost estimates from practical data which will better inform cost-effectiveness and budget impact analyses.