The Partners Demonstration Project – Kabwohe Clinical Research Centre

Title:

An open-label, pilot demonstration and evaluation project of antiretroviral-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples.

Primary Objectives:

To evaluate the ability to do targeted enrollment of higher-risk HIV-1 serodiscordant couples into a longitudinal HIV-1 prevention study.
To assess user preferences among high-risk HIV-1 serodiscordant couples for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners.
To ascertain initiation of and adherence to PrEP among HIV-1 uninfected partners, when implemented as a bridge to ART.
To ascertain initiation of and adherence to ART among HIV-1 infected partners.
To assess factors influencing preferences, uptake and adherence for antiretroviral-based HIV-1 prevention.
To assess the feasibility of PrEP discontinuation in couples in which the HIV-1 infected partner initiates ART.
To assess PrEP use and birth outcomes among HIV-1 uninfected women who choose to continue PrEP during pregnancy.

Design:

Prospective, observational, open-label cohort study Up to 24 months of follow-up per couple.

Population:

Heterosexual HIV-1 serodiscordant couples in Kenya and Uganda who did not participate in the Partners PrEP Study (approximately 1000 couples in total).

Study sites:

Thika, Kenya; Kampala, Uganda; Kisumu, Kenya; and Kabwohe, Uganda Partners PrEP Study sites.

Approach:

We are enrolling couples with characteristics defining higher HIV-1 transmission risk (i.e., to target those for ART/PrEP that are at greatest risk for HIV-1, a public health priority). We will provide or refer HIV-1 infected participants to ART services following national ART initiation guidelines, recognizing that guidelines for ART initiation (including potentially recommending ART for all HIV-1 infected members in serodiscordant relationships) may change during the course of the study. PrEP will be offered to the HIV-1 uninfected partners as a “bridge” to ART initiation and viral suppression in the partnership; uptake and adherence to PrEP will be measured. Specifically, PrEP as a bridge to ART will be done as follows: when the HIV-1 infected partner is not yet taking ART, PrEP will be offered, and if the HIV-1 infected partner initiates ART, PrEP will be discontinued for the HIV-1 uninfected partner six months later (i.e., once viral suppression in the HIV-1 infected partner would be expected to be typically achieved). We will conduct mixed-methods work to understand user preferences, couples decision-making, risk perception, fertility intentions, and barriers to uptake of and adherence to both PrEP and ART.