Clinical trial NCT03832530: Periconception PrEP for HIV-exposed Ugandan Women
Official title: Adherence to Periconception HIV Risk-reduction Among Uninfected Women in Rural Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: PrEP
conception
prevention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
First posted: 2019-02-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Safer conception counseling
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Self Report Inclusion Criteria:

1. Female
2. Aged 18-35
3. Likely to be fertile based on reproductive health history \[55\]
4. Reported personal or partner desire to have a child in the next year \[56-59\]
5. With a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed).
6. Live within 60km of clinic. Not planning on relocating to an area incompatible with ability to attend quarterly clinic over a 9-month follow-up period

Objective Inclusion Criteria:

1. HIV-negative (onsite rapid testing)
2. Not currently pregnant (onsite urine b-hcg testing)
3. Fluent in English or local language
4. Otherwise able to participate in the informed consent process

Exclusion Criteria

1. Currently pregnant
2. HIV-positive

Primary outcomes:
measure: Uptake of PrEP
timeFrame: 9 months
Secondary outcomes:
measure: Adherence to PrEP, daily pill taking behavior
timeFrame: 9 months
measure: Adherence to PrEP, plasma levels
timeFrame: 9 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
References:
citation: Atukunda EC, Owembabazi M, Pratt MC, Psaros C, Muyindike W, Chitneni P, Bwana MB, Bangsberg D, Haberer JE, Marrazzo J, Matthews LT. A qualitative exploration to understand barriers and facilitators to daily oral PrEP uptake and sustained adherence among HIV-negative women planning for or with pregnancy in rural Southwestern Uganda. J Int AIDS Soc. 2022 Mar;25(3):e25894. doi: 10.1002/jia2.25894.