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Clinical Trials/NCT02139176
NCT02139176
Completed
Not Applicable

Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program

University of North Carolina, Chapel Hill1 site in 1 country200 target enrollmentMarch 2014
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of North Carolina, Chapel Hill
Enrollment
200
Locations
1
Primary Endpoint
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.

This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.

Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.

Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
January 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years old or 16-17 years old and married
  • Received a positive HIV-test within the last day
  • Will be in Lilongwe for the next month
  • Able and willing to give locator information for \>1 male partner in the Bwaila District Hospital catchment area (either a mobile number, a physical address, or both)

Exclusion Criteria

  • Enrolled/enrolling in the PROMISE study
  • Initially Presenting with a male sex partner

Outcomes

Primary Outcomes

Number of Women Who Came With Their Partners and Received Couple Counseling and Testing

Time Frame: three months

Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.

Secondary Outcomes

  • Female First Option B+ Follow-up Visit(three months)
  • Male Linkage to Care(one month from male presentation to the clinic)

Study Sites (1)

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