Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi

Not Applicable

Completed

• Conditions: Hiv
• Interventions: Behavioral: Enhanced Couple HIV Testing and Counseling

• Registration Number: NCT03477279
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address help address 1) poor male engagement in the HIV continuum of care, 2) low male adoption of biomedical HIV prevention approaches, 3) sub-optimal female engagement in the continuum of care, and 4) poor or uncertain infant outcomes. Our team has developed an intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year. Women with recent HIV infections enrolled in this trial will be compared against a cohort of 350 HIV-uninfected women to explore predictors of HIV acquisition in pregnancy in Malawi.

Detailed Description

In sub-Saharan Africa, engaging HIV-infected men in HIV care and treatment and engaging HIV-uninfected men in prevention has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors. They are less likely to seek HIV testing and counseling (HTC), initiate combination antiretroviral therapy (cART), and be retained in cART care. Poor care-seeking has resulted in a lower prevalence of viral suppression and earlier mortality. Additionally, men rarely engage in the antenatal care-seeking of their female sexual partners, leading to worse maternal and infant outcomes. This low level of engagement has been noted in Malawi's Option B+ prevention of mother to child transmission (PMTCT) program, and has been a critical barrier to female Option B+ uptake and retention, and a missed opportunity for engaging men.

There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address all of these challenges: poor male engagement in the HIV continuum of care, low male adoption of biomedical HIV prevention approaches, sub-optimal female engagement in the continuum of care, and poor or uncertain infant outcomes. Our team has designed a couples-based intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year. Results from this study are expected to inform how best to address family outcomes in an Option B+ program.

This study has the following aims described below:

Aim 1: Determine whether the couple-based intervention increases new HIV-positive diagnoses among HIV-infected male sex partners, helps HIV-infected men engage and remain in care, and contributes to male viral suppression compared to individual standard of care. The investigators will compare the couple-based intervention to standard of care for increasing the proportion of men who are aware of being HIV-infected, the proportion of these men who initiate and remain in cART care, and the proportion of these men with viral suppression at one year.

Aim 2: Determine whether the couple-based intervention identifies HIV-discordant couples and decreases the likelihood of male exposure to HIV compared to individual standard of care. The investigators will compare the intervention to standard of care for increasing the number of men with non-HIV exposure from their female partner through consistent condom use, viral suppression, abstinence, or a combination of these methods over one year.

Aim 3: Determine whether the couple-based intervention improves female cART retention and viral suppression compared to individual standard of care. The investigators will compare the intervention to standard of care for female cART retention and viral suppression at one year.

Aim 4: Determine whether the couple-based intervention improves infant early infant diagnosis uptake compared to individual standard of care. Explore uptake of early infant diagnosis and rates of mother-to-child transmission and child survival in the two intervention arms.

Aim 5: Develop an in-depth understanding of HIV transmission dynamics in Lilongwe. Using the biomarkers and behavioral survey, we will seek to understand transmission timing, direction, and context in Lilongwe. We will compare women with recent HIV infection to a population of HIV-uninfected controls (n=350) to understand predictors of HIV acquisition in pregnancy in Malawi.

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Primary Completion: 2020-07-21
• Study Completion: 2020-09-30
• Status Verified: 2021-03
• Results First Submitted: 2021-04-30
• Results First Submitted QC: 2021-06-03
• Last Update Submitted: 2021-06-03
• Results First Posted: 2021-06-24
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1116

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Couple (Intervention)	Enhanced Couple HIV Testing and Counseling	In addition to receiving standard of care procedures, HIV-infected pregnant women in the couple arm will be provided with an intervention aimed at recruiting their male partners, providing enhanced couple counseling and testing, engaging their male partners in their care, and supporting male partners to receive care and treatment services.

Primary Outcome Measures

Name	Time	Method
Number of HIV-positive Male Partners Aware of Their HIV-positive Status	12 months	HIV-positive male partners who presented at 12 months and reported knowing they were HIV-positive prior to receiving the results of the HIV test conducted at the 12 month study visit
Number of HIV-negative Men Without HIV Exposure From Their Primary Partner	12 months	HIV-negative men with a) consistent condom use in the last six months or b) a suppressed female partner or c) abstinence with primary partner
Number of Women Retained in Care	12 months	Women who presented at 12 months and reported taking at least one dose of ART in the last seven days
Number of HIV-positive Male Partners Retained in Care	12 months	HIV-positive male partners who presented at 12 months and reported taking at least one dose of ART in the last seven days
Number of HIV-positive Male Partners With Viral Suppression	12 months	HIV-positive male partners who presented at 12 months with a viral load \<1000 copies/mL
Number of Women With Viral Suppression	12 months	Women who presented at 12 months with a viral load \<1000 copies/mL

Secondary Outcome Measures

Name	Time	Method
Number of HIV-positive Female Participants Who Reported Early Infant Diagnosis	12 months	HIV-positive female participants who reported a live birth and uptake of early infant diagnosis
Predictors of Recent HIV Infection	At the day of female consent	Risk factor analysis to identify predictors of recent HIV infection among pregnant women

Trial Locations

Locations (1)

Bwaila District Hospital Antenatal Unit; 🇲🇼 Lilongwe, Central District, Malawi