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Periconception PrEP for HIV-exposed Ugandan Women

NCT03832530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-05-26

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Mbarara University of Science and Technology

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2019-04-01
Completion
2020-12-30

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832530 on ClinicalTrials.gov