| Protocol No: | ECCT/22/06/01 | Date of Protocol: | 02-02-2022 |
| Study Title: |
A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women
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| Study Objectives: |
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| 1 | 1. To estimate HIV incidence using the recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort. 2. To assess the characteristics of women who initiate PrEP compared to those who do not initiate PrEP. 3. To evaluate young women’s preferences for attributes of long-acting formulations of PrEP, using a discrete choice experiment. 4. To assess the acceptability of a patient-facing PrEP decision support tool to provide young women more informed choice about PrEP options. 5. Assess HLA genotypes to determine the breadth of variants present in young women from East and southern Africa |
| Laymans Summary: | The World Health Organization recommends daily oral tenofovir based PrEP for the prevention of HIV infection in persons at significant HIV risk. Three of the four million young people living with HIV in Africa are young women <25 years of age. PrEP would be most impactful if young African women at highest risk of HIV infection are motivated to use PrEP and are able to establish daily pill-taking habits and sustain high adherence while they remain at risk. The main aim of this study is to evaluate open-label PrEP delivery and PrEP preferences among African women. |
| Abstract of Study: | Background: WHO recommends daily oral tenofovir based PrEP for preventing HIV infection in persons at significant HIV risk. Young African women are at substantial risk of HIV infection and PrEP has been shown to be highly effective with high adherence. PrEP delivery, uptake and adherence need to be optimized for young African women for a greater impact. Justification: Young African women are an important population for PrEP implementation, having high annual HIV incidence rates of 5-6%. PrEP has been demonstrated to be highly effective in HIV prevention when adherence is high. However, PrEP persistence has been a challenge in open-label studies and programmatic delivery. Understanding strategies to support PrEP persistence and user values and preferences related to long-acting PrEP are needed. This open-label cohort study will evaluate PrEP uptake, use, persistence and preferences among young women to assess opportunities to optimize PrEP for young African women. Objectives: Objectives of this study will be evaluated in sexually active HIV negative cisgender women aged 16-30 years. The study aims to evaluate open-label PrEP delivery and PrEP preferences among African women. The specific objectives are: 1) To estimate HIV incidence using the recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort.; 2) To Assess the characteristics of women who initiate PrEP compared to those who do not initiate PrEP; 3) Evaluate young women’s preferences for attributes of long-acting formulations of PrEP, using a discrete choice experiment; and 4) To assess the acceptability of a patient-facing PrEP decision support tool to provide young women more informed choice about PrEP options.. Methods: This study will offer a PrEP delivery package within a prospective cohort study of sexually active HIV negative cisgender women ages 16-30 to understand PrEP uptake, use, persistence and preferences for attributes of PrEP products and PrEP delivery with a focus on long-acting PrEP. Up to 150 women will be enrolled in our site in Kisumu.
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| 1 | Background: WHO recommends daily oral tenofovir based PrEP for preventing HIV infection in persons at significant HIV risk. Young African women are at substantial risk of HIV infection and PrEP has been shown to be highly effective with high adherence. PrEP delivery, uptake and adherence need to be optimized for young African women for a greater impact. Justification: Young African women are an important population for PrEP implementation, having high annual HIV incidence rates of 5-6%. PrEP has been demonstrated to be highly effective in HIV prevention when adherence is high. However, PrEP persistence has been a challenge in open-label studies and programmatic delivery. Understanding strategies to support PrEP persistence and user values and preferences related to long-acting PrEP are needed. This open-label cohort study will evaluate PrEP uptake, use, persistence and preferences among young women to assess opportunities to optimize PrEP for young African women. Objectives: Objectives of this study will be evaluated in sexually active HIV negative cisgender women aged 16-30 years. The study aims to evaluate open-label PrEP delivery and PrEP preferences among African women. The specific objectives are: 1) To estimate HIV incidence using the recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort.; 2) To Assess the characteristics of women who initiate PrEP compared to those who do not initiate PrEP; 3) Evaluate young women’s preferences for attributes of long-acting formulations of PrEP, using a discrete choice experiment; and 4) To assess the acceptability of a patient-facing PrEP decision support tool to provide young women more informed choice about PrEP options; 5) To assess HLA genotypes to determine the breadth of variants present in young women from East and southern Africa. Methods: This study will offer a PrEP delivery package within a prospective cohort study of sexually active HIV negative cisgender women ages 16-30 to understand PrEP uptake, use, persistence and preferences for attributes of PrEP products and PrEP delivery with a focus on long-acting PrEP. Up to 150 women will be enrolled in our site in Kisumu. |