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Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi

NCT03477279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1116

Last updated 2021-06-24

Study results available
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Summary

There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address help address 1) poor male engagement in the HIV continuum of care, 2) low male adoption of biomedical HIV prevention approaches, 3) sub-optimal female engagement in the continuum of care, and 4) poor or uncertain infant outcomes. Our team has developed an intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year. Women with recent HIV infections enrolled in this trial will be compared against a cohort of 350 HIV-uninfected women to explore predictors of HIV acquisition in pregnancy in Malawi.

Conditions

Interventions

BEHAVIORAL

Enhanced Couple HIV Testing and Counseling

Participants are provided study-specific partner referral cards and encouraged to bring male partners to antenatal care for a male engagement intervention. Those who do not present on their own are then traced. Couples will receive three enhanced couple counseling sessions that include: pre-test counseling, return of joint results, and post-test counseling. HIV-infected men will be able to initiate cART at the antenatal clinic and the couple will be offered condoms from the HTC counselor. Between sessions, couple members can pick up condoms and cART for one another.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Nora E Rosenberg, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2020-07-21
Completion
2020-09-30

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

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 NCT03477279 on ClinicalTrials.gov