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. Author manuscript; available in PMC: 2019 Apr 1.
Published in final edited form as: Matern Child Nutr. 2017 Oct 10;14(2):e12545. doi: 10.1111/mcn.12545

Male partner involvement on initiation and sustainment of exclusive breastfeeding among HIV-infected postpartum women: Study protocol for a randomized controlled trial

Dorothy Ihekuna 1, Neal Rosenburg 2, William Nii Ayitey Menson 3, Semiu Olatunde Gbadamosi 3, John Olajide Olawepo 4, Adaeze Chike-Okoli 5, Chad Cross 2, Chima Onoka 5, Echezona E Ezeanolue 3
PMCID: PMC5867189  NIHMSID: NIHMS907497  PMID: 29024499

Abstract

Exclusive Breast Feeding (EBF) among HIV-infected mothers is known to be associated with a sustained and significant reduction in HIV transmission and has the potential to reduce infant and under-five mortality. Research shows that EBF is not common in many HIV endemic, resource-limited settings despite recommendations by the World Health Organization. Although evidence abounds that male partner involvement increases HIV testing and uptake and retention of PMTCT interventions, few studies have evaluated the impact of male partners' involvement and decision-making on initiation, maintenance, and sustainment of EBF.

We propose a comparative effectiveness trial of Men's Club as intervention group (MC-IG) compared to the control group (MC-CG) on initiation and sustainment of EBF. Men's Club will provide male partners of HIV-infected pregnant women one five-hour interactive educational intervention to increase knowledge on EBF and explore barriers and facilitators of EBF and support. Additionally, participating male partners in the MC-IG will receive weekly text message reminders during the first 6-week postnatal period to improve initiation and sustainment of EBF. Participants in the MC-CG will receive only educational pamphlets. Primary outcomes are the differences in the rates of initiation and sustainment of EBF at six months between the two groups. Secondary outcomes are differences in male partner knowledge of infant feeding options and the intent to support EBF in the two groups.

Understanding the role and impact of male partners on the EBF decision-making process will inform the development of effective and sustainable evidence-based interventions to support the initiation and sustainment of EBF.

Keywords: Breastfeeding, male involvement, HIV, randomized controlled trial, resource-limited setting, Nigeria

Introduction

As of 2015, there were 36.7 million people living with HIV worldwide (UNAIDS, 2015). Young women were found to be at a disproportionately high risk of HIV infection, accounting for 20% of new infections among adults globally in 2015. This disparity is more glaring in sub-Saharan Africa (SSA), where women accounted for 56% of all new infections and young women accounted for 25% of all new HIV infections among adults (UNAIDS, 2016). In addition, 15% of all women living with HIV are aged 15- 24 years, of whom 80% live in SSA (UNAIDS, 2014).

Nigeria, the most populous country in Africa, is one of twenty-one priority countries in SSA that, together with India, account for 90% of pregnant women infected with HIV (UNAIDS, 2014). Globally, Nigeria has the 2nd largest number of: a) people living with HIV, b) new HIV infections, and c) pregnant women living with HIV. In 2013, only 17.1% of women of reproductive age received an HIV test in the preceding 12 months. Of the 190,000 HIV-infected women who delivered in Nigeria, only 27% received antiretroviral therapy (ART) for prevention of mother-to-child HIV transmission (PMTCT) compared to 68% in SSA (UNAIDS, 2014). In 2015, 27% of all new childhood HIV infections worldwide occurred in Nigeria (UNAIDS, 2016).

Breastfeeding remains the optimal mode of feeding for infants younger than six months (Govender & Coovadia, 2014). Exclusive Breast Feeding (EBF) among HIV-infected mothers on antiretroviral medications 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 (Govender & Coovadia, 2014; Rose, Hall, & Martinez-Alier, 2014). Although EBF has been shown as an evidence-based approach for PMTCT and infant wellbeing, the practice remains low in many HIV-endemic, resource-limited settings (Wood, Woods, Blackburn, & Sanders, 2016a). A recent study involving 1629 infants showed that EBF rates declined from 85% at 2 months to < 30% by 4 months with the highest drop off in the first postpartum month (Manji et al., 2016). Further, studies have shown that stigma negatively impacts the uptake of EBF among both HIV-positive and HIV-negative women (Odeny et al., 2016). Without health education, peer counselor engagement, and male partner support, extensive promotion of EBF for 6 months in prevention of mother-to-child HIV transmission (PMTCT) programs could inadvertently result in stigma due to women's perceived association of EBF with HIV infection (Wood, Woods, Blackburn, & Sanders, 2016b). In a recent study conducted in southeast Nigeria, researchers determined that pressure from family members and cultural practices impede EBF practices (Madiba & Letsoalo, 2013). Women often initiate the decision on EBF during or after counseling in the antenatal period. In practice, many are not able to sustain that decision as family beliefs, cultural practices and social circumstances in their homes impact decisions to adhere or depart from their original choice of feeding (Leshabari, Blystad, & Moland, 2007; Matji et al., 2008; Njunga & Blystad, 2010; Thairu, Pelto, Rollins, Bland, & Ntshangase, 2005; Wettstein et al., 2012). Understanding the role and impact of male partners on this decision-making process requires further scrutiny to inform the development of effective and sustainable evidence-based interventions to support the initiation and sustainment of EBF.

There is the need for novel approaches that integrate female and male partner infant feeding decision-making. A recent systematic review and meta-analysis of missed opportunities for PMTCT indicates that to be effective, approaches need to be feasible, acceptable, integrated, family-centered and sustainable (Sherr & Croome, 2012). Fathering is a crucial component of the family and child experience; however, health care facilities and services do not always engage males in many cases (Lawani et al., 2014).. A recent study shows that the engagement of male partners in the care continuum, both in households and health care facilities increases the proportion of women who breastfeed at four and six months postpartum (Bich et al., 2014). Additionally, a recent study from Makurdi, Nigeria indicates that the noninvolvement of male partners was a major barrier preventing the use of PMTCT services (Anigilaje & Olutola, 2013). Given the considerable authority among men as decision makers in sub-Saharan African (Olugbenga-Bello, Asekun-Olarinmoye, Adewole, Adeomi, & Olarewaju, 2013), we may be witnessing a missed opportunity to engage men in the education, awareness and decision-making for EBF. A woman's stated intention to breastfeed is one of the strongest predictors of breastfeeding initiation and duration (Meedya, Fahy, & Kable, 2010). Evidence on male partner's involvement and intent to support EBF is scant in the literature.

Preliminary studies

Intervention for Sustained Testing and Retention among HIV-infected Women- The iSTAR study

The Men's Club study is a supplement to the National Institute of Health (NIH) funded 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 difference in linkage and engagement rates between iSTAR and the clinic-based control group (CG). Secondary outcomes are difference in retention and viral suppression rate.

The Healthy Beginning initiative (HBI)

The Healthy Beginning initiative was an NIH-funded study. This grant was a cluster randomized comparative effectiveness trial designed to evaluate the comparative effectiveness of a church-based confidential, free integrated laboratory tests provided on-site during ‘baby showers’ for pregnant women and their male partners on HIV testing and PMTCT completion. This trial was conducted in Southeast Nigeria between January 20, 2013 and August 31, 2014 and the intervention was associated with a higher HIV testing rate (CG=54.6% [740/1355] vs. IG =91.9% [1514/1647]; [AOR= 11.2; 95% CI: 8.77-14.25, P-value=<0.001](Ezeanolue et al., 2015). Like the iSTAR study, HBI utilized a network of church-based health advisors and clinic-based teams trained in motivational interviewing; quality improvement skills to engage and support HIV-infected women.

Participants and methods

Aims and hypotheses

Specific aims

  1. Determine the impact of Men's Club intervention on male partner's knowledge of infant feeding options and intent to support exclusive breastfeeding versus the control group.

  2. Determine the impact of Men's Club intervention on initiation of exclusive breastfeeding among HIV-infected women.

  3. Determine the impact of Men's Club on the exclusivity of breastfeeding among HIV-infected women.

Hypotheses

For the three respective aims described above, we hypothesize that;

  1. Knowledge of breastfeeding options and intent to support exclusive breastfeeding will increase by at least 20% among Men's Club participants compared to the control group.

  2. Female partners of men who participate in Men's Club intervention will be at least 20% more likely to initiate exclusive breastfeeding when compared to the control group.

  3. The rate of exclusive breastfeeding for 6 months will be 20% higher among children born to Men's Club participants compared to the control group.

Trial design

Using a two-arm, randomized trial design, we will evaluate the effectiveness of Men's Club, an intervention that provides male partners of HIV-infected pregnant women, one five-hour interactive educational intervention to increase knowledge of EBF and phone support versus the control group on the initiation and sustainment of EBF. A total of 100 couples in Benue state, north-central Nigeria, will be randomly assigned to either the IG (N = 50 couples) or the CG (N= 50 couples). The primary outcomes are the difference in the rates of initiation and sustainment of EBF between the two groups. The secondary outcomes are the difference in knowledge of feeding options among male partners and rate of sustained EBF among the female participants in the two groups at 6 months post-delivery.

Settings and participants

This proposed study is nested within the ongoing NIH-funded iSTAR parent study. As such, the study will be conducted in the seven priority local governments in Benue state, north-central Nigeria. Benue state was selected as the site for the proposed study because its overall HIV sero-prevalence of 5.6% is close to the national average of 3.4% (NACA, 2014); in 2012, the state was projected to have a population of 5,138,53 with 49.6% females and fertility rate of 4.9% (National Bureau of Statistics, 2015); and preliminary findings from the iSTAR study suggest HIV prevalence rates among pregnant women across the seven local government areas ranging from 4.3% to 10.8%.

Participant recruitment and randomization

Our proposed study will be conducted among 100 couples or partners, age > 18 years, participating in the recruitment process of the ongoing iSTAR trial. Trained research staff will contact eligible female subjects by telephone to provide an overview of the study. If a female subject indicates interest, the research staff will schedule a meeting at her local church to provide more detailed study information. During the meeting, if the female subject gives consent to participate in the study, she will be screened on the availability of her male partner and whether they are living together. If the male partner is available, a research staff will contact him by phone to provide an overview of the study. The male partner will also be invited to the local church to receive more study information. If he chooses to participate and gives consent, the couple will be enrolled in the study. If either partner refuses to participate in the study at any point of the process, their recruitment will be terminated (Figure 1).

Figure 1. Men's Club study recruitment flow diagram.

Figure 1

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Inclusion criteria

Couples/Partners living together identified during iSTAR recruitment (church-organized baby showers of the HBI program)

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.

To account for potential differences among participants [50 in the intervention group; 50 in the control group], 4 groups will be included in this study. First, 50 HIV-infected females will be randomly selected from the subject pool in the iSTAR study database. Second, 50 HIV-negative females will be selected from this same pool. Third, these females will be pair-matched by HIV (whether positive or negative)status to form 50 pairs. Subsequently, each of the 50 pairs of females will be randomized to either MC-IG or MC-CG. The male partners will follow their female partners' randomization until a total of 100 couples have been enrolled (25 in each of the 4 combinations: MC-IG (HIV-infected female/male partner); MC-CG (HIV-infected female/male partner); MC-IG (HIV-negative female/male partner); and MC-CG (HIV-negative female/male partner).

Staff recruitment and training

Trained research assistants in the ongoing iSTAR study will collect data for this study. These research staff have already undergone training that covered data collection, ethics and the underpinning protocol for the iSTAR study. They will receive further training that will cover the Men's Club protocol, breastfeeding and additional data collection responsibilities. The training will be conducted by Dr. Dorothy Ihekuna, an investigator in this study. Her experience as a master trainer in breastfeeding and nutrition for community and health facility-based nutrition programs and in HIV patients is one of the many factors that will be relied upon to accomplish our objectives.

Study Procedure

Description of the intervention group

Interactive session

This will be a one-day five-hour session that will take place at the respective churches, and will be facilitated by trained lactation nurses. Each session will involve a maximum of ten male participants, and will occur during the female partner's third 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 (Figure 2). The educational information session will be guided by the Government of Nigeria's Community and Infant and Young Child Feeding (IYCF) counselling package training manual. The manual is an adaptation of the UNICEF and World Health Organization 2006 Infant and Young Child Feeding Integrated Counselling Course harmonized with the national policy on infant feeding in the context of HIV in Nigeria. Key information topics will include the importance of and factors that affect infant feeding, recommended breastfeeding practices, common breastfeeding difficulties, women's nutrition and infant feeding in the context of HIV. At the end of the session, participants in the intervention group will receive educational pamphlets on breastfeeding to reinforce the knowledge gained during these activities. These pamphlets will contain simplified messages about the importance of breastfeeding, the role of the father, exclusive breastfeeding in the context of HIV among others.

Figure 2. Flow diagram for randomized control trial.

Figure 2

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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 (Table 1). 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. The calls will be used to reinforce the content of the educational pamphlets.

Table 1. Topics for weekly robocalls.
Time point Key Topics
1st week Why Infant and Young Child Feeding Matters
2nd week Common Situations that can Affect Infant and Young Child Feeding
3rd week Recommended Infant and Young Child Feeding Practices: Breastfeeding
4th week Common Breastfeeding Difficulties: Symptoms, Prevention, and ‘What to Do’
5th week Women's Nutrition
6th week Infant and Young Child Feeding in the Context of HIV
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Description of the control group

Male participants in the control group will receive only educational pamphlets related to breastfeeding during the third trimester of their female partner's pregnancy.

Qualitative study

Focus groups

We will collect data during the study visits to inform the selection process for the focus groups. There will be three sets of FGDs: males only, females only and mixed. These data will provide us with the needed information to recruit a homogenous group of participants through purposive sampling for the focus groups. The discussion will be scheduled to be held during the period that corresponds to a time point of 6 months post-delivery for female participants. The focus groups will examine barriers and facilitators that may hinder or contribute to the initiation and sustainment of exclusive breastfeeding. All data will be analyzed using Nvivo software and Krueger's framework analysis approach which provides a clear series of step for qualitative data analysis - familiarization, identifying a thematic framework, indexing and charting (i.e. managing the data, data reduction), mapping and interpretation (Castleberry, 2012),(Krueger, 1998) .

Outcome measures

The primary outcomes are the difference in the rates of (i) initiation and (ii) sustainment of EBF between the two groups. Initiation of EBF is defined as the provision of mother's breast milk to infants within one hour of birth collected during a study visit at 6 weeks post-partum. Sustainment of EBF is defined as exclusive breastfeeding at 3 months collected at this time point.

The secondary outcomes are the difference in (i) knowledge of feeding options among male partners and (ii) rate of sustained EBF among the female participants in the two groups at 6 months post-delivery. The Breastfeeding Knowledge Questionnaire will be used to collect information from each male partner on knowledge of feeding at the prenatal time point and 6 weeks postpartum. Additionally, the Iowa Infant Feeding Attitudes Scale (De La Mora, Russell, Dungy, Losch, & Dusdieker, 1999) and the Breastfeeding Self-Efficacy scale (Dennis & Faux, 1999) will be used to assess attitudes towards infant feeding in each male partner and self-efficacy of breastfeeding practices in each female respectively at 6 weeks post-delivery.

Data collection

Each questionnaire will be administered to participants by research staff during the proposed study visit that will occur at 1 month pre-delivery, 6 weeks post-delivery, 3 months post-partum and 6 months post-partum. Additionally, we will abstract sociodemographic data of participants from the iSTAR trial database.

Sample size estimation

The general statistical approach for this study is based on a four-group, pre-to-post change based on a structured educational intervention. The proposed sample size of 25 men in each arm is adequate to measure a change of at least 20% between the groups with 80% power, α = .05, and correlation between repeated measures of 0.5. Based on these assumptions, a minimal sample size of 19 participants in each group is needed; hence, our proposed over-sample will account for potential drop-outs of 30%. Additionally, Aims 2 and 3 assess differences in proportions, and the sample sizes are adequate to measure a 20% difference with 95% power.

Statistical Analysis Plan

Aim 1 will be assessed using the pre-to-post scores from the Breastfeeding Knowledge Questionnaire administered at a 10-week interval (1 month prior to delivery and 6 weeks postpartum). A repeated-measures analysis accounting for within- and between-subjects factors will be examined. This is equivalent to assessing the post-intervention scale scores using the pre-intervention scores as a covariate, which assures that the true differences are more likely related to the intervention than to random factors. In this analysis, both iSTAR and MC groups will initially be considered as between-subjects factors. In the event that iSTAR randomization is not a significant factor, samples will be combined to increase sample size for the MC-IG/CG comparisons. Aims 2 and 3 hypothesize a proportional difference of at least 20% between IG and CG. These aims will be assessed using an exact proportion test to determine the differences in initiation of EBF (Aim 2) and the rate of exclusivity of EBF (Aim 3), with the IG expected to be proportionally higher than the CG on all measures. Proportion tests will be structured to initially compare the two iSTAR-IGs to each other and the two iSTAR-CGs to each other. If iSTAR randomization is not significant in these comparisons, then samples will be combined to increase sample sizes for the MC-IG/CG proportion tests. Owing to multiple tests, p-values will be adjusted using a conservative Bonferroni approach.

Ethical considerations

All patient data will be kept in locked computers, accessible only to study personnel. Ethics approval has been obtained from the Institutional Review Boards (IRB) of the University of Nevada, Las Vegas and the University of Nigeria, Nsukka. This trial was registered on ClinicalTrials.gov, under the identifier number NCT03072758. No monetary or material support has been received for this study.

Discussion

In this protocol, we outline an innovative approach that works through the use of educational sessions and phone support to determine the impact of our intervention on rates of (i) initiation and (ii) sustainment of EBF. Several studies have examined the effectiveness of interventions such as short message service, educational sessions, intensive interpersonal counselling and phone support that were primarily focused on the females, in increasing uptake of exclusive breastfeeding (Gallegos, Russell-Bennett, Previte, & Parkinson, 2014; Flax et al., 2016). However, interventions delivered through a community-based approach that targets male partners to improve breastfeeding practices in females have not been adequately studied. As such, our proposed study is significant for the following reasons: Firstly, it focuses on male partners with a clear understanding of the considerable influence that they have on female behavior. This influence has been seen with increased HIV testing, uptake of PMTCT intervention and contraceptives when male partners become engaged (Haile & Brhan, 2014; Vouking, Evina, & Tadenfok, 2014). Secondly, it builds upon a timely, well-designed randomized trial that leverages an ongoing study that recruits and screens 10,000 pregnant women for HIV, hepatitis B virus infection and sickle cell genotype, and subsequently enrolls 400 HIV-infected women into the parent study. Thirdly, it utilizes a data triangulation approach to increase the validity (quantitative) and transferability/credibility (qualitative) of any findings.

Conclusion

Understanding the role and impact of male partners on the EBF decision-making process will inform the development of effective and sustainable evidence-based interventions to support the initiation and sustainment of EBF.

Key messages.

  • Exclusive Breast Feeding (EBF) among HIV-infected mothers on antiretroviral medications is associated with a significant reduction in HIV transmission

  • The decline in exclusive breastfeeding rates in the first few months after birth, especially among HIV-infected mothers is associated with cultural practices and stigma, especially in our study setting

  • We will test the impact of male involvement on initiation and sustainment of exclusive breastfeeding for a period of six months

  • We will make use of the influence of male partnerson women's breastfeeding behaviors

Acknowledgments

Source of funding: Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number R01HD087994 and Grant Number 3R01HD087994-01S1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health

Abbreviations

AIDS

Acquired Immune Deficiency Syndrome

ART

Antiretroviral therapy

EBF

Exclusive Breast Feeding

HBI

Healthy Beginning Initiative

HIV

Human Immunodeficiency Virus

iSTAR

Intervention for sustained testing and retention

IYCF

Infant and Young Child Feeding

MC-CG

Men's Club-Control Group

MC-IG

Men's Club-Intervention Group

NIH

National Institutes of Health

PMTCT

Prevention of Mother-to-Child Transmission

SSA

Sub-Saharan Africa

UNLV

University of Nevada, Las Vegas

UNN

University of Nigeria, Nsukka

Footnotes

Conflict of interest statement: Authors declare no competing interests.

Contributions: EEE, NR and CO conceived the study; DI, EEE, NR, JOO, CC and AC designed the study; DI, WNAM and SOG drafted the manuscript; all authors revised and approved the final manuscript.

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