NCT03832530

Periconception PrEP for HIV-exposed Ugandan Women

Adherence to Periconception HIV Risk-reduction Among Uninfected Women in Rural Uganda

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
BEHAVIORAL	Safer conception counseling inclusive of periconception PrEP	Observational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month. Maximum 19 month follow-up period (through pregnancy outcome).

Timeline

• Start date: 2017-11-27
• Primary completion: 2019-04-01
• Completion: 2020-12-30
• First posted: 2019-02-06
• Last updated: 2021-05-26

Locations

1 site across 1 country: Uganda