HIV Infections Clinical Trial
Official title:
Men's Club: Impact of Male Partner Involvement on Initiation and Sustainment of Exclusive Breastfeeding Among Postpartum Women
Breastfeeding remains the optimal mode of feeding for infants younger than six months.
Exclusive Breast Feeding (EBF) among HIV-infected mothers has been shown to be associated
with a sustained and significant reduction in HIV transmission and has the potential to
reduce infant and under-five mortality.
Given the considerable authority among men as decision makers in sub-Saharan African, we may
be witnessing a missed opportunity to engage men in the education, awareness, and
decision-making for EBF. Understanding the role and impact of male partners on this
decision-making process require further examination to inform the development of effective
and sustainable evidence-based interventions to support the initiation and sustainment of
EBF.
Summary of the Parent Grant (R01HD087994): The parent grant is a cluster randomized
comparative effectiveness trial designed to test the effectiveness of an integrated
intervention for sustained testing and retention (iSTAR) on linkage, engagement, and
retention among women with HIV infection. The iSTAR intervention provides: confidential,
onsite integrated laboratory testing during baby showers; a network of church-based health
advisors; clinic based teams trained in motivational interviewing; quality improvement skills
to engage and support HIV-infected women; and integrated case management to reduce loss to
follow-up. Primary outcomes are the difference in linkage and engagement rates between iSTAR
and the clinic-based control group (CG). The secondary outcomes are the difference in
retention and viral suppression rate.
Building upon the parent grant, this administrative supplement grant will assess the
comparative effectiveness of Men's Club (MC) as intervention group (MC-IG) compared to the
control group (MC-CG) on the initiation and sustainment of exclusive breastfeeding. Men's
Club is an integrated intervention where male participants receive a five-hour
interactive/educational session during their partner's pregnancy, and weekly phone reminders
during the first six-week postnatal period to increase EBF knowledge and support strategies,
and to improve sustainment of EBF respectively. Male partners in MC-CG will not receive the
proposed intervention. Additionally, we will explore barriers and facilitators to support and
sustainment of exclusive breastfeeding among participants from both MC-IG and MC-CG in the
study. The Primary Outcome is the difference in the rate of initiation and sustainment of EBF
between the two groups. The Secondary Outcome is the difference in knowledge of feeding
options among male partners and rate of sustained EBF among the female partners in the two
groups at 6 months post-delivery.
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