Protocol No: ECCT/18/07/04 Date of Protocol: 25-05-2018

Study Title:

Evaluation of Expedited partner therapy/Partner HIV self-testing for young women enrolled in POWER study and diagnosed with sexually transmitted infections in Kisumu

Study Objectives:

Main objective To evaluate the acceptability, feasibility, barriers and unintended consequences of EPT and HIVST.

Specific objectives

1. We will evaluate uptake and acceptability to expedited partner treatment (EPT) and partner HIV self-testing among HIV-uninfected young women diagnosed with chlamydia or gonorrhea.

2. To explore experiences, preferences, barriers and facilitators related to expedited partner treatment and partner HIV self-testing.

3. To assess STI reinfection rates in relation to uptake of expedited partner therapy.

4. To explore unintended consequences related to expedited partner treatment and partner HIV self-testing.

Laymans Summary:

Determining ways to prevent and treat sexually transmitted infections in young HIV-uninfected women is a priority for HIV prevention. For women using pre-exposure prophylaxis (PrEP), screening and treatment of STIs is recommended. Expedited Partner Therapy and HIVST could provide a useful approach to treat partners of HIV-uninfected women diagnosed with an STI to prevent STI reinfection. In the context of an ongoing PrEP implementation study among young women The POWER study, we propose to evaluate the acceptability, feasibility, barriers and unintended consequences of EPT and HIVST in women who test positive for chlamydia and/or gonorrhea in Jaramogi Oginga Odinga Teaching and Referral Hospital’s family planning clinic and Kisumu Medical and Education Trust’s family planning clinic, in Kisumu with an aim of developing sustainable models for partner treatment by informing policy on STI partner treatment and HIV self-testing.

Abstract of Study:

Worldwide, the prevalence and incidence of Sexually Transmitted Infections (STIs) is high. In the ongoing Prevention Options for Women Evaluation Research (POWER) cohort study where Pre-Exposer Prophylaxis (PrEP) is being delivered to young women aged 16 to 25 in Kisumu Kenya, we have seen a high incidence of Chlamydia trachomatis and Neisseria gonorrhoeae infections (23% and 11%, respectively) and therefore, strategies to reduce STIs rates in the context of PrEP is a priority. Expedited partner Therapy (EPT) is one of the strategies that has been proved in clinical trials to reduce the recurrence of STIs. EPT is the clinical practice of treating the sex partners of patients diagnosed with a STI (usually Chlamydia trachomatis or Neisseria gonorrhoeae) by providing medications to the patient to take to his/her partner without the health care provider first examining the partner. This study seeks to evaluate the acceptability, feasibility, barriers and unintended consequences of EPT and HIV self-testing (HIVST). We will prospectively observe sexually active young HIV negative women ages 16 to 25 years enrolling in the POWER cohort study in Jaramogi Oginga Odinga Teaching and Referral Hospital’s (JOOTRH) public family planning clinic and Kenya Medical and Education Trust’s (KMET) private family planning clinic, in Kisumu. We will enroll young women whose urine sample test positive for chlamydia and/or gonorrhea at either of the two delivery sites. They will be offered STI treatment and HIV self-test kits for their partner(s) and measure the proportion who agree to take EPT and/or HIV self-test kits to their partner(s) compared to the Standard of Care (SOC). Using quantitative and qualitative methods to evaluate the uptake and acceptability of EPT and partner HIVST, exploring experiences, preferences, barriers and facilitators related to EPT and partner HIV self-testing, and assessing STI reinfection rates in relation to EPT with a view to Inform policy on STI partner treatment and HIV self-testing.