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      A community-based mobile clinic model delivering PrEP for HIV prevention to adolescent girls and young women in Cape Town, South Africa

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          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.

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          Preexposure prophylaxis for HIV infection among African women.

          Lut Van Damme, Amy Corneli, Khatija Ahmed … (2012)
          Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P<0.001, and P=0.03, respectively). Rates of drug discontinuation because of hepatic or renal abnormalities were higher in the TDF-FTC group (4.7%) than in the placebo group (3.0%, P=0.051). Less than 40% of the HIV-uninfected women in the TDF-FTC group had evidence of recent pill use at visits that were matched to the HIV-infection window for women with seroconversion. The study was stopped early, on April 18, 2011, because of lack of efficacy. Prophylaxis with TDF-FTC did not significantly reduce the rate of HIV infection and was associated with increased rates of side effects, as compared with placebo. Despite substantial counseling efforts, drug adherence appeared to be low. (Supported by the U.S. Agency for International Development and others; FEM-PrEP ClinicalTrials.gov number, NCT00625404.).
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            “Scaling-out” evidence-based interventions to new populations or new health care delivery systems

            Gregory Aarons, Marisa Sklar, Brian Mustanski … (2017)
            Background Implementing treatments and interventions with demonstrated effectiveness is critical for improving patient health outcomes at a reduced cost. When an evidence-based intervention (EBI) is implemented with fidelity in a setting that is very similar to the setting wherein it was previously found to be effective, it is reasonable to anticipate similar benefits of that EBI. However, one goal of implementation science is to expand the use of EBIs as broadly as is feasible and appropriate in order to foster the greatest public health impact. When implementing an EBI in a novel setting, or targeting novel populations, one must consider whether there is sufficient justification that the EBI would have similar benefits to those found in earlier trials. Discussion In this paper, we introduce a new concept for implementation called “scaling-out” when EBIs are adapted either to new populations or new delivery systems, or both. Using existing external validity theories and multilevel mediation modeling, we provide a logical framework for determining what new empirical evidence is required for an intervention to retain its evidence-based standard in this new context. The motivating questions are whether scale-out can reasonably be expected to produce population-level effectiveness as found in previous studies, and what additional empirical evaluations would be necessary to test for this short of an entirely new effectiveness trial. We present evaluation options for assessing whether scaling-out results in the ultimate health outcome of interest. Conclusion In scaling to health or service delivery systems or population/community contexts that are different from the setting where the EBI was originally tested, there are situations where a shorter timeframe of translation is possible. We argue that implementation of an EBI in a moderately different setting or with a different population can sometimes “borrow strength” from evidence of impact in a prior effectiveness trial. The collection of additional empirical data is deemed necessary by the nature and degree of adaptations to the EBI and the context. Our argument in this paper is conceptual, and we propose formal empirical tests of mediational equivalence in a follow-up paper.
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              HIV pre‐exposure prophylaxis for adolescent girls and young women in Africa: from efficacy trials to delivery

              Connie L Celum, Sinead Delany-Moretlwe, Jared Baeten … (2019)
              Abstract Introduction Adolescent girls and young women (AGYW) in Africa have high HIV incidence despite scale‐up of HIV testing and HIV treatment. Placebo‐controlled trials of tenofovir‐based pre‐exposure prophylaxi (PrEP) in diverse populations demonstrated that PrEP works with close to 100% effectiveness if taken with high, but not perfect, adherence. Divergent efficacy estimates among African AGYW led to demonstration and implementation projects to better understand motivations for HIV prevention, uptake, adherence and persistence to PrEP. To inform PrEP programmes, the design and initial findings from PrEP demonstration projects for AGYW are reviewed. Discussion Early lessons from PrEP implementation projects among young African women include: (1) awareness and demand creation with positive messaging about the benefits of PrEP are critical to motivate AGYW to consider this novel prevention technology and to foster awareness among peers, partners, parents and guardians to support AGYW's effective PrEP use; (2) PrEP initiation is high in projects that are integrating PrEP into youth‐friendly clinics, family planning clinics and mobile clinics; (3) young African women at risk are initiating PrEP, based on behavioural characteristics, history of intimate partner violence, depression and 30% prevalence of chlamydia and/or gonorrhoea; (4) provision of youth‐friendly PrEP delivery programmes that integrate reproductive health services, including contraception and the diagnosis and treatment of sexually transmitted infections, increase health impact; (5) messages that emphasize the necessity for high adherence while at potential risk of HIV exposure and support strategies that addresses AGYW's adherence challenges are essential; and, (6) a substantial proportion of AGYW do not persist with PrEP, and strategies are needed to help AGYW assess their ongoing need, motivation and challenges with persisting with PrEP. Conclusions PrEP is feasible to implement in integrated reproductive health service delivery models to reach African AGYW. While PrEP demonstration projects indicate that women with behavioural risks and high rates of sexually transmitted diseases are initiating PrEP; effective strategies to support AGYW's adherence and persistence with PrEP are needed. Lessons learned from oral PrEP delivery, a novel first generation HIV prevention product, are relevant to longer‐acting and less adherence‐dependent strategies which are currently in clinical trials.
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                Author and article information

                Contributors
                Elzette Rousseau: (View ORCID Profile)
                Journal
                Title: BMC Health Services Research
                Abbreviated Title: BMC Health Serv Res
                Publisher: Springer Science and Business Media LLC
                ISSN (Electronic): 1472-6963
                Publication date Created: December 2021
                Publication date (Electronic): August 28 2021
                Publication date (Print): December 2021
                Volume: 21
                Issue: 1
                Article
                DOI: 10.1186/s12913-021-06920-4
                SO-VID: d17870e2-3c60-45b9-96df-c6e919a740ae
                Copyright © © 2021
                License:

                https://creativecommons.org/licenses/by/4.0

                https://creativecommons.org/licenses/by/4.0

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