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

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).

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: patient referral; Behavioral: contract referral

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Central District
    • Lilongwe, Central District, Malawi
      • Bwaila District Hospital Antenatal Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient referral; Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information	Behavioral: patient referral; A patient agrees to recruit their partner using the invitation.; Other Names: passive referral; patient notification; invitation only
Experimental: contract referral; Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.	Behavioral: patient referral; A patient agrees to recruit their partner using the invitation.; Other Names: passive referral; patient notification; invitation only; Behavioral: contract referral; A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.; Other Names: partner notification; contract partner notification; invitation plus tracing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing	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.	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female First Option B+ Follow-up Visit	It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared.	three months
Male Linkage to Care	It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center.	one month from male presentation to the clinic

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Nora E Rosenberg, PhD, University of North Carolina, Chapel Hill; Principal Investigator: Mina Hosseinipour, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: HIV; disclosure; couple HIV testing and counseling; Malawi; discordant
• Other Study ID Numbers: 13-3707