Men's Club: Impact of Male Partner Involvement on Initiation and Sustainment of Exclusive Breastfeeding Among Postpartum Women

NCT03072758 | Unknown DMC

• 1 other identifier: 959559-3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Breastfeeding, Exclusive

Keywords

Male partner involvement

Outcome Measures

Primary Outcomes (3)

• Initiation of breastfeeding

  Provision of mother's breast milk to infants within one hour of birth; participant self-report during face-to-face interview at 6 weeks post-partum

  6 weeks

• Sustainment of exclusive breastfeeding

  Any/exclusive breastfeeding at 3 months is measured using a structured questionnaire at 3 months postnatal

  3 months

• Difference in rates of sustainment of exclusive breastfeeding

  Any/exclusive breastfeeding at 6 months is measured using a structured questionnaire at 6 months postnatal

  6 months

Secondary Outcomes (2)

• Difference in breastfeeding knowledge

  Baseline and 6 weeks

• Attitudes towards breastfeeding

  6 weeks

Study Arms (2)

Men's Club Intervention Group

EXPERIMENTAL

Participants randomized to this group will receive interventions from the study team.

Behavioral: Men's Club

Men's Club Control Group

NO INTERVENTION

Male participants in the control group will receive only education pamphlets related to breastfeeding during the 3rd trimester of their female partner's pregnancy

Interventions

Men's Club BEHAVIORAL

Interactive session: This will be a one-day five-hour session that will take place at the church, and will be facilitated by trained lactation nurses. This will involve a maximum of 10 male participants and will occur during the female partner's 3rd trimester. Male partners will (a) complete a structured questionnaire to determine baseline knowledge, attitudes and beliefs about breastfeeding practices, and (b) actively engage in educational information on the benefit of exclusive breastfeeding. At the end of the session, the participants will receive educational pamphlets on breastfeeding to reinforce all the information that had been provided. Phone call reminders: Participants will receive weekly robocalls during the first six weeks following the birth of the infant to reinforce the benefits of exclusive breastfeeding. This will be an automated service that will deliver the calls at a specific time of the day the participants have indicated on their questionnaire.

Men's Club Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• University Of Nigeria Teaching Hospital: collaborator
• Catholic Caritas Foundation, Nigeria: collaborator

Study Sites (1)

Catholic Caritas Foundation

Makurdi, Benue State, Nigeria

Location

MeSH Terms

Conditions

HIV Infections; Breast Feeding

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health and Pediatrics

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: March 30, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 31, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)