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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02139176
• Other study ID #: 13-3707
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2014
• Last updated: November 14, 2014
• Start date: March 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2014
• Source: University of North Carolina, Chapel Hill
• Contact: Nora E Rosenberg, PhD
• Phone: +265 (0)99 109 0676
• Email: Nora_Rosenberg[@]unc.edu
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV

Intervention

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.
• patient referral
A patient agrees to recruit their partner using the invitation.

Locations

Country	Name	City	State
Malawi	Bwaila District Hospital Antenatal Unit	Lilongwe	Central District

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of couple HIV counseling and testing	It will be assessed 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). We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.	three months	No
Secondary	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). Time to first visit will be assessed using a Kaplan Meier curve and a log rank test.	three months	No
Secondary	Male linkage to care	It will be assessed whether 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. We will use the Kaplan Meier method to plot outcomes and a log rank test to compare time to linkage to care between arms.	one month	No