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The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)

NCT03049176 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2019-09-30

No results posted yet for this study

Summary

This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

Conditions

  • HIV Infections

Interventions

DRUG

PrEP (Truvada)

oral, daily Truvada for HIV-negative participants

DRUG

Antiretrovirals

oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant

PROCEDURE

Semen washing

collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination

PROCEDURE

Artificial vaginal insemination

collection of semen from an HIV-negative man, followed by intravaginal insemination

Sponsors & Collaborators

Principal Investigators

  • Joelle M Brown, PhD, MPH · University of California, San Francisco

  • Felix Mhlanga, MBChB, MMed · UZ-UCSF Collaborative Research Programme

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2019-06-03
Completion
2019-07-31

Countries

  • Zimbabwe

Study Locations

More Related Trials

Entities

Companies

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 NCT03049176 on ClinicalTrials.gov