Periconception PrEP for HIV-exposed Ugandan Women

Status Completed

Clinical Trial Summary

In this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence and determinants of uptake and adherence (tenofovir plasma concentration >40ng/mL, opening pill device to take >80% of dispensed pills) to PrEP and other safer conceptions strategies among Ugandan women exposed to HIV.

Clinical Trial Description

The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus unknown partner and personal or partner pregnancy plans. Eligible women will participate in comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The primary outcomes are to evaluate uptake of and adherence to periconception PrEP among HIV-exposed women in rural Uganda. To accomplish this, women will participate in quarterly study visits, HIV and pregnancy testing, questionnaires and safer conception/adherence group counseling sessions. Participants will be eligible to initiate PrEP at any time during the first 6 months of the 9-month study follow-up period. Participants who initiate PrEP will use an electronic pill cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV at quarterly study visits. For women who become pregnant in the first 9 months, investigators will follow them up through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes. Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) . Investigators will offer objective sexually transmitted infection (STI) testing to all participants in order to measure the prevalence, incidence, and factors associated with STIs. Investigators will compare incidence among women who choose and who do not choose PrEP. Investigators will also measure the number of episodes of condomless sex each month as a mediator variable for STI development. ;

Study Design

Related Conditions & MeSH terms

HIV Prevention

Clinical Trial Details

NCT number	NCT03832530
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	N/A
Start date	November 27, 2017
Completion date	December 30, 2020

View Details

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