Periconception PrEP for HIV-exposed Ugandan Women

NCT03832530 | Completed

• 1 other identifier: 2017P001853
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention

Keywords

PrEP; conception; prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adherence to PrEP, daily pill taking behavior

  9 months

• Adherence to PrEP, plasma levels

  9 months

Study Arms (1)

HIV-uninfected women

EXPERIMENTAL

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

Interventions

Safer conception counseling inclusive of periconception PrEP BEHAVIORAL

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).

HIV-uninfected women

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Aged 18-35
• Likely to be fertile based on reproductive health history \[55\]
• Reported personal or partner desire to have a child in the next year \[56-59\]
• 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).
• 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
• HIV-negative (onsite rapid testing)
• Not currently pregnant (onsite urine b-hcg testing)
• Fluent in English or local language
• Otherwise able to participate in the informed consent process

You may not qualify if:

• Currently pregnant
• HIV-positive

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mbarara University of Science and Technology: collaborator

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Related Publications (2)

• Matthews LT, Atukunda EC, Owembabazi M, Kalyebera KP, Psaros C, Chitneni P, Hendrix CW, Marzinke MA, Anderson PL, Isehunwa OO, Hurwitz KE, Bennett K, Muyindike W, Bangsberg DR, Haberer JE, Marrazzo JM, Bwana MB. High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study. PLoS Med. 2023 Feb 16;20(2):e1004088. doi: 10.1371/journal.pmed.1004088. eCollection 2023 Feb.

  PMID: 36795763 DERIVED

• 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.

  PMID: 35324081 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Safer conception counseling

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: February 6, 2019
• Study Start: November 27, 2017
• Primary Completion: April 1, 2019
• Study Completion: December 30, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

UG (1)