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

Primary Purpose

HIV Infections, Breastfeeding, Exclusive

Status
Unknown status
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Men's Club
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring Male partner involvement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Catholic Caritas Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Men's Club Intervention Group

Men's Club Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Sustainment of exclusive breastfeeding
Any/exclusive breastfeeding at 3 months is measured using a structured questionnaire at 3 months postnatal
Difference in rates of sustainment of exclusive breastfeeding
Any/exclusive breastfeeding at 6 months is measured using a structured questionnaire at 6 months postnatal

Secondary Outcome Measures

Difference in breastfeeding knowledge
Breastfeeding Knowledge Questionnaire (survey) at prenatal timepoint and 6 weeks postpartum
Attitudes towards breastfeeding
Iowa Infant Feeding Attitudes Scale (survey) at 6-weeks post delivery

Full Information

First Posted
March 2, 2017
Last Updated
October 24, 2017
Sponsor
University of Nevada, Las Vegas
Collaborators
University Of Nigeria Teaching Hospital, Catholic Caritas Foundation, Nigeria
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1. Study Identification

Unique Protocol Identification Number
NCT03072758
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
March 15, 2018 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
Collaborators
University Of Nigeria Teaching Hospital, Catholic Caritas Foundation, Nigeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Breastfeeding, Exclusive
Keywords
Male partner involvement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Men's Club Intervention Group
Arm Type
Experimental
Arm Description
Participants randomized to this group will receive interventions from the study team.
Arm Title
Men's Club Control Group
Arm Type
No Intervention
Arm Description
Male participants in the control group will receive only education pamphlets related to breastfeeding during the 3rd trimester of their female partner's pregnancy
Intervention Type
Behavioral
Intervention Name(s)
Men's Club
Intervention Description
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.
Primary Outcome Measure Information:
Title
Initiation of breastfeeding
Description
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
Time Frame
6 weeks
Title
Sustainment of exclusive breastfeeding
Description
Any/exclusive breastfeeding at 3 months is measured using a structured questionnaire at 3 months postnatal
Time Frame
3 months
Title
Difference in rates of sustainment of exclusive breastfeeding
Description
Any/exclusive breastfeeding at 6 months is measured using a structured questionnaire at 6 months postnatal
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference in breastfeeding knowledge
Description
Breastfeeding Knowledge Questionnaire (survey) at prenatal timepoint and 6 weeks postpartum
Time Frame
Baseline and 6 weeks
Title
Attitudes towards breastfeeding
Description
Iowa Infant Feeding Attitudes Scale (survey) at 6-weeks post delivery
Time Frame
6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Catholic Caritas Foundation
City
Makurdi
State/Province
Benue
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No

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

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