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

Study 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).

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

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: contract referral
* Behavioral: patient referral


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient referral<br>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<br>* A patient agrees to recruit their partner using the invitation.<br>* Other names: invitation only;|
| Experimental: contract referral<br>Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. | Behavioral: contract referral<br>* A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.<br>* Other names: invitation plus tracing;Behavioral: patient referral<br>* A patient agrees to recruit their partner using the invitation.<br>* Other names: invitation only;|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, couple HIV testing and counseling, disclosure, discordant, Malawi