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

University of North Carolina (UNC)

Status: Completed

Conditions: HIV

Treatments: Behavioral: patient referral; Behavioral: contract referral

Study type: Interventional

Funder types: Other

Identifiers

NCT02139176

13-3707

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years old or 16-17 years old and married

  • Pregnant
  • 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Patient referral

Active Comparator group

Description:

Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information

Treatment:

Behavioral: patient referral

contract referral

Experimental group

Description:

Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

Treatment:

Behavioral: contract referral

Behavioral: patient referral