Protocol No: ECCT/19/11/02 Date of Protocol: 24-09-2019

Study Title:

PrEP and dPEP: Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis

Study Objectives:

1. Evaluate the effectiveness of doxycycline post-exposure prophylaxis (PEP) to reduce STI infections in HIV-uninfected Kenyan women taking HIV PrEP

2. Assess the safety, tolerability, and acceptability of dPEP

3. Assess adherence to dPEP

4. Investigate the impact of dPEP on tetracycline resistance in N. gonorrhoeae and C. trachomatis

5. Measure the cost of dPEP and estimate the cost per case averted, budget impact, and affordability.

Laymans Summary:

In recent times, young women in Africa are twice as likely to acquire a new HIV infection compared to their male counterparts. They are also more affected with multiple health risks from common sexually transmitted infections like gonorrhea, chlamydia and syphilis which are all preventable and treatable. PrEP is known to prevent HIV when taken as prescribed. Past research has also shown that doxycline medication can treat STIs like chlamydia, syphilis and gonorrhea. We would therefore like to find out whether using dPEP among young Kenyan women already taking PrEP will reduce disease burden in this group. We will carry out an investigation to compare one group taking dPEP with another group receiving standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 women taking PrEP (1:1 allocation, 223 per group). We will target women from ages 18 to 30 years old and the study will take place in Lumumba and Jaramogi, Oginga Odinga Teaching and Referral Hospital. We will follow up the women for 12 months. The study will aim to assess whether dPEP is acceptable, safe, and tolerable by understanding challenges and motivators of dPEP use and adherence to dPEP and PrEP. Additionally we will evaluate the cost and impact of using dPEP in controlling new infections and complications. We will carry out indepth interviews, focus group discussions with women on PrEP and also ask them questions to understand their study acceptability and changes in their sexual behavior due to dPEP

Abstract of Study:

Sub-Saharan Africa has a high rate of new HIV infections. Each year, over two million people are reported to be newly infected, the majority of whom are young African women (under age 30). Women account for more than half of the new infections in Africa. They also face a disproportionate burden of sexually transmitted infections (STIs). The consequences of bacterial STIs on sexual and reproductive health can be profound. This study seeks to evaluate the effectiveness of doxycycline post-exposure prophylaxis (dPEP) to reduce STIs in HIV-uninfected women aged 18 – 30 years who are taking HIV pre-exposure prophylaxis (PrEP) in Kisumu, Kenya. The study aims to assess whether dPEP is acceptable, safe, and tolerable by understanding challenges and motivators of dPEP use and adherence to dPEP and PrEP We will conduct an open-label randomized trial of dPEP versus standard of care among 446 women taking PrEP and follow them for 12 months. We will employ a mixed methods research approach, including use of quantitative questionnaires, focus group discussions (FGDs), short message service (SMS) and individual indepth interviews (IDIs) to study acceptability and changes in sexual behavior due to dPEP. We will collect data specific to women to evaluate if dPEP is effective, safe, acceptable, tetracycline resistance inducing, and cost effective to inform public health policy.