scholarly journals 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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Andrew Medina-Marino ◽  
Dana Bezuidenhout ◽  
Sybil Hosek ◽  
Ruanne V. Barnabas ◽  
Millicent Atujuna ◽  
...  

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.govNCT03977181. Registered on 6 June 2019—retrospectively registered.

2020 ◽  
Author(s):  
Deborah Baron ◽  
Fiona Scorgie ◽  
Lethabo Ramskin ◽  
Nomhle Khoza ◽  
Jennifer Schutzman ◽  
...  

Abstract Background: Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV infection in adolescent girls and young women if used consistently during periods of risk. The EMPOWER study evaluated peer-based clubs incorporating an empowerment curriculum offered to adolescent girls and young women (16-24 years) in South Africa and Tanzania for adherence support. Methods: Using serial in-depth interviews (n=33), we assessed the benefits and challenges of club attendance among 13 EMPOWER participants in the Johannesburg site who were randomised to clubs. We used a summary matrix of coded data to support a narrative, case-based analysis. Four case studies are presented. Results: Club participants reported benefits such as increased self-esteem and self-efficacy, reduced isolation, and greater insight into gender-based violence and strategies to address it. Day-to-day PrEP adherence was not the only topic discussed in clubs; participants also appreciated the safe space for sharing problems (such as relationship conflict and PrEP stigma) and found interactive exercises helpful in improving partner communication.Conclusions: Findings support the use of peer-based clubs using a structured empowerment approach, which may offer valuable PrEP initiation support to adolescent girls and young women in settings with high HIV and gender-based violence prevalence.Trial registration: South African Clinical Trial Register 4353, 15 April 2016


2020 ◽  
Author(s):  
Deborah Baron ◽  
Fiona Scorgie ◽  
Lethabo Ramskin ◽  
Nomhle Khoza ◽  
Jennifer Schutzman ◽  
...  

Abstract Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV infection in adolescent girls and young women if used consistently during periods of risk. The EMPOWER study evaluated peer-based clubs incorporating an empowerment curriculum offered to adolescent girls and young women (16-24 years) in South Africa and Tanzania for adherence support. Using serial in-depth interviews (n=33), we assessed the benefits and challenges of club attendance among 13 EMPOWER participants in the Johannesburg site who were randomised to clubs. We used a summary matrix of coded data to support a narrative, case-based analysis. Four case studies are presented. Club participants reported benefits such as increased self-esteem and self-efficacy, reduced isolation, and greater insight into gender-based violence and strategies to address it. Day-to-day PrEP adherence was not the only topic discussed in clubs; participants also appreciated the safe space for sharing problems and found interactive exercises helpful in improving partner communication. Findings support the use of peer-based clubs using a structured empowerment approach, which may offer valuable PrEP initiation support to adolescent girls and young women in settings with high HIV and gender-based violence prevalence.


2020 ◽  
Author(s):  
Deborah Baron ◽  
Fiona Scorgie ◽  
Lethabo Ramskin ◽  
Nomhle Khoza ◽  
Jennifer Schutzman ◽  
...  

Abstract Background: Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV infection in adolescent girls and young women if used consistently during periods of risk. The EMPOWER study evaluated peer-based clubs incorporating an empowerment curriculum offered to adolescent girls and young women (16-24 years) in South Africa and Tanzania for adherence support. Methods: Using serial in-depth interviews (n=33), we assessed the benefits and challenges of club attendance among 13 EMPOWER participants in the Johannesburg site who were randomised to clubs. We used a summary matrix of coded data to support a narrative, case-based analysis. Four case studies are presented. Results: Club participants reported benefits such as increased self-esteem and self-efficacy, reduced isolation, and greater insight into gender-based violence and strategies to address it. Day-to-day PrEP adherence was not the only topic discussed in clubs; participants also appreciated the safe space for sharing problems (such as relationship conflict and PrEP stigma) and found interactive exercises helpful in improving partner communication.Conclusions: Findings support the use of peer-based clubs using a structured empowerment approach, which may offer valuable PrEP initiation support to adolescent girls and young women in settings with high HIV and gender-based violence prevalence.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maya Jackson-Gibson ◽  
Ashley Uzoamaka Ezema ◽  
Wicklife Orero ◽  
Irene Were ◽  
Ramael Osasogie Ohiomoba ◽  
...  

Abstract Background While the introduction of HIV Pre-Exposure Prophylaxis (PrEP) as an HIV prevention strategy has allowed women to exercise more control over the reduction of HIV transmission rates, adolescent girls and young women in Sub-Saharan Africa continue to experience higher rates of HIV infections and bear the greatest disease burden. Understanding progress in PrEP uptake among adolescent girls and young women would enhance risk reduction in this vulnerable population. The Determined, Resilient, AIDS-Free, Mentored and Safe women (DREAMS) Initiative plays a key role in this risk reduction strategy. Methods We performed a qualitative study to explore facilitators and barriers to PrEP implementation and assess factors effecting initiation and persistence on PrEP among adolescent girls and young women enrolled in the DREAMS Initiative at Pamoja Community Based Organization in Kisumu, Kenya. We conducted key informant interviews (n = 15) with Pamoja Community Based Organization staff, health care providers and community leaders. Additionally, we conducted focus group discussions with young women receiving PrEP and peer mentors (n = 40). We performed a directed content analysis using the Consolidated Framework for Implementation Research to organize the identified facilitators and barriers. Results We found that the use of the safe space model, decentralization of PrEP support and delivery, peer mentors, effective linkage to local health care facilities, the sensitization of parents and male sexual partners, disclosure of PrEP use by beneficiaries, active stakeholder involvement and community engagement were among some of the facilitators to PrEP uptake. Barriers to PrEP implementation, initiation and persistence included stigma associated with the use of anti-retroviral drugs, drug side effects, frequent relocation of beneficiaries, limited resources for routine screening and medication monitoring, and a limited number of qualified health care workers for PrEP distribution and administration. Conclusion Overall, the community roll-out of PrEP within the DREAMS Initiative was successful due to a number of key facilitating factors, which ultimately led to successful PrEP implementation, increased PrEP initiation and enhanced persistence among adolescent girls and young women. The identified barriers should be addressed so that a larger scale-up of PrEP roll-out is possible in the future.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elzette Rousseau ◽  
Linda-Gail Bekker ◽  
Robin F. Julies ◽  
Connie Celum ◽  
Jennifer Morton ◽  
...  

Abstract Background Daily 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. Methods We 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. Results A 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. Conclusions PrEP 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.


2020 ◽  
Author(s):  
Deborah Baron ◽  
Fiona Scorgie ◽  
Lethabo Ramskin ◽  
Nomhle Khoza ◽  
Jennifer Schutzman ◽  
...  

Abstract Background: Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV infection in adolescent girls and young women if used consistently during periods of risk. The EMPOWER study evaluated peer-based clubs incorporating an empowerment curriculum offered to adolescent girls and young women (16-24 years) in South Africa and Tanzania for adherence support. Methods: Using serial in-depth interviews (n=33), we assessed the benefits and challenges of club attendance among 13 EMPOWER participants in the Johannesburg site who were randomised to clubs. We used a summary matrix of coded data to support a narrative, case-based analysis. Four case studies are presented. Results: Club participants reported benefits such as increased self-esteem and self-efficacy, reduced isolation, and greater insight into gender-based violence and strategies to address it. Day-to-day PrEP adherence was not the only topic discussed in clubs; participants also appreciated the safe space for sharing problems (such as relationship conflict and PrEP stigma) and found interactive exercises helpful in improving partner communication.Conclusions: Findings support the use of peer-based clubs using a structured empowerment approach, which may offer valuable PrEP initiation support to adolescent girls and young women in settings with high HIV and gender-based violence prevalence.Trial registration: Pan African Clinical Trials Registry PACTR202006754762723, 10 June 2020, retrospectively registered


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