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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT02139176
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 10.1
• Patients Per Site Per Month: 19.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HIV	Behavioral: contract referral; Behavioral: patient referral	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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: 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 ; Behavioral: patient referral; A patient agrees to recruit their partner using the invitation.; Other Names: passive referral patient notification invitation only

Outcome Measures

Primary Outcome Measures

1. Number of Women Who Came With Their Partners and Received Couple Counseling and Testing [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 Outcome Measures

1. Female First Option B+ Follow-up Visit [three months]

   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.

2. Male Linkage to Care [one month from male presentation to the clinic]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bwaila District Hospital Antenatal Unit	Lilongwe	Central District	Malawi

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02139176
• Other Study ID Numbers: 13-3707
• First Posted: May 15, 2014
• Last Update Posted: Aug 7, 2017
• Last Verified: Sep 1, 2016

• Keywords provided by University of North Carolina, Chapel Hill: couple HIV testing and counseling; disclosure; discordant; HIV; Malawi

Study Results

Participant Flow

Arm/Group Title	Patient Referral	Contract Referral
Arm/Group Description	Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. 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.
Period Title: Overall Study
STARTED	100	100
COMPLETED	100	100
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Patient Referral	Contract Referral	Total
Arm/Group Description	Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. 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.	Total of all reporting groups
Overall Participants	100	100	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.5 (0.49)	26.6 (0.50)	26.6 (0.35)
Sex: Female, Male (Count of Participants)
Female	100 100%	100 100%	200 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Referral	Contract Referral
Arm/Group Description	Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. 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.
Measure Participants	100	100
Number [Female participants receiving CHTC]	52 52%	70 70%

2. Secondary Outcome

Title	Female First Option B+ Follow-up Visit
Description	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.
Time Frame	three months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient Referral	Contract Referral
Arm/Group Description	Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. 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.
Measure Participants	100	100
Number [participants]	83 83%	91 91%

3. Secondary Outcome

Title	Male Linkage to Care
Description	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.
Time Frame	one month from male presentation to the clinic

Outcome Measure Data

Analysis Population Description

These are only the HIV-infected men who participated in the study who were HIV-infected and not already engaged in care. That is why it is only a subset of the larger population.

Arm/Group Title	Patient Referral	Contract Referral
Arm/Group Description	Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. 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.
Measure Participants	26	33
Number [partners linked to care]	5	15

Adverse Events

Arm/Group Title	Patient Referral		Contract Referral
Arm/Group Description	Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.		Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. 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.
All Cause Mortality
	Patient Referral		Contract Referral
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Patient Referral		Contract Referral
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Patient Referral		Contract Referral
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		3/100 (3%)
Social circumstances
social disruptions reported by women	0/100 (0%)	0	3/100 (3%)	3
social disruption reported by men	0/100 (0%)	0	1/100 (1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.