Periconception PrEP for HIV-exposed Ugandan Women

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Safer conception counseling inclusive of periconception PrEP

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Mbarara, Uganda
    • Mbarara University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HIV-uninfected women; A sample of 150 women, aged 18-35, likely to be fertile based on reproductive health history, with reported personal or partner desire to have a child in the next year and who self-reports having a relationship 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). All women are offered comprehensive safe conception counseling -- this is the intervention -- inclusive of daily oral TDF/FTC as PrEP.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of PrEP	Measure prevalence (measured by the proportion of women who collect the first 3 month supply of drug) TDF/FTC PrEP for safer conception	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to PrEP, daily pill taking behavior	We will measure the proportion of women who achieve daily adherence to at least 80% of PrEP through electronic pill count measurement	9 months
Adherence to PrEP, plasma levels	We will measure the proportion of women who achieve TFV plasma levels consistent with taking medication (detectable) and taking enough medication to confer protection (=>40ng/mL).	9 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Mbarara University of Science and Technology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 22, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: PrEP; prevention; conception
• Other Study ID Numbers: 2017P001853

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes