Clinical trial NCT03072758: Men's Club: Impact of Male Partner Involvement on Initiation and Sustainment of Exclusive Breastfeeding Among Postpartum Women
Official title: Men's Club: Impact of Male Partner Involvement on Initiation and Sustainment of Exclusive Breastfeeding Among Postpartum Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Breastfeeding, Exclusive
Keywords: Male partner involvement
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: University Of Nigeria Teaching Hospital
name: Catholic Caritas Foundation, Nigeria
First posted: 2017-03-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Cohabiting couples/partners; residing in Benue state, Nigeria identified during iSTAR recruitment (baby showers)

Exclusion Criteria:

* HIV-infected females who have not disclosed their status to their male partners; male partners who do not own a phone; multiple pregnancy; and any health-related condition that prevents the female partner from breastfeeding.

Primary outcomes:
measure: Initiation of breastfeeding
timeFrame: 6 weeks
measure: Sustainment of exclusive breastfeeding
timeFrame: 3 months
measure: Difference in rates of sustainment of exclusive breastfeeding
timeFrame: 6 months
Secondary outcomes:
measure: Difference in breastfeeding knowledge
timeFrame: Baseline and 6 weeks
measure: Attitudes towards breastfeeding
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Makurdi
country: Nigeria
facility: Catholic Caritas Foundation
state: Benue
Study officials:
References: