The Impact of Mentor Mothers on PMTCT Service Outcomes in Nigeria

NCT01936753 | Completed DMC

• 2 other identifiers: IHVN_WHO_PMTCT_MoMentRPC531
• Study Type: interventional
• Target: 497
• Locations: 1 country
• Sites: 1

Brief Summary

Nigeria has significant challenges in the delivery and coverage of PMTCT (Prevention of mother-to-child transmission of HIV) services. Only 30% of pregnant women living with HIV are provided anti-retroviral drugs for PMTCT. Less than 10% of HIV-exposed infants receive HIV testing for early diagnosis by age 2 months. Furthermore, an unacceptably high number of women with HIV who are enrolled in PMTCT programs do not complete them. In other words, uptake and retention in PMTCT programs in Nigeria is not adequate. Ultimately, mother-to-child transmission of HIV is high, resulting in a high number of new child HIV infections. Mentor Mothers (MMs) are women living with HIV who provide peer support to other HIV-positive women. MM programs have been incorporated into PMTCT programs in several African countries with some success, but with varying levels of MM training and program structure. The MoMent (MOther MENTor) study investigates whether highly-structured MM programs will further improve uptake and successful completion of PMTCT services (eg testing and appointments) in Nigeria. The study also evaluates the impact of structured MM programs on other outcomes, including facility deliveries, new infant HIV infections, infant survival and maternal viral suppression. Rural areas are the focus of this study because of their particularly poor performance in PMTCT coverage and outcomes.

Conditions

HIV

Keywords

PMTCT; HIV; Mentor Mothers; Nigeria; Retention; Adherence

Outcome Measures

Primary Outcomes (2)

• Proportion of HIV-exposed infants presenting for DNA PCR testing by 2 months of age.

  Early infant diagnosis (EID) is defined as the collection and processing of an HIV DNA PCR test for an HIV-exposed infant by 2 months of age. EID is done to ensure that HIV-positive infants will be promptly enrolled into HIV treatment programs and can start lifesaving Antiretroviral Therapy (ART) in timely fashion.

  At 2 months (62 days) of age for the HIV-exposed infant.

• Proportion of HIV-positive mothers retained in PMTCT care at 6 months post-delivery.

  Maternal retention is determined by evaluating for at least 1 clinic visit made for each 30-day period for the first 180 days postpartum. The proportion of women making at least 3 of 6 monthly appointments are designated retained; this proportion is calculated for each study arm.

  At 180 days (6 months) post-delivery

Secondary Outcomes (3)

• Maternal viral suppression at 6 months postpartum

  6 months (169 to 197 days) post-delivery

• Proportion of infants HIV-positive at 2 and 6 months post-delivery.

  At 2 months (62 days) and at 6 months (197 days) post-delivery.

• Proportion of HIV-positive mothers retained in PMTCT care at 12 months post-delivery.

  At 360 days (12 months) post-delivery

Study Arms (2)

Mentor Mother Peer Support

EXPERIMENTAL

This is an enhanced behavioral intervention. Mentor Mothers trained with a standard study curriculum are assigned to pregnant HIV-positive women accessing care at Primary Healthcare Centers in study communities. Under close daily supervision, Mentor Mothers provide support and counseling for the mother-infant pairs until the exposed infant is 12 months old. Study participants in this arm also receive standard of care PMTCT services.

Behavioral: Trained Mentor Mother and Supervisor

Routine Peer Support

NO INTERVENTION

Pregnant HIV-positive women receive standard-of-care PMTCT services (drugs, appointments, tests). These women are, per routine, assigned peer counselors who are also HIV-positive women with PMTCT experience but who do receive little or no standardized formal training, and are not closely supervised.

Interventions

Trained Mentor Mother and Supervisor BEHAVIORAL

Trained, closely supervised Mentor Mothers guide and support the mother-infant pair to achieve timely and complete access to, and retention in PMTCT services along the entire cascade.

Mentor Mother Peer Support

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Only HIV-positive pregnant females are eligible for recruitment. All infants born live to these females are also enrolled.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant and HIV-positive
• years of age and above

You may not qualify if:

• Working or ever worked as a Mentor Mother
• Presenting in labor
• Does not plan to continue receiving services at study site

Sponsors & Collaborators

• Institute of Human Virology, Nigeria: lead
• University of Maryland: collaborator
• Federal Ministry of Health, Nigeria: collaborator

Study Sites (1)

Nadia Sam-Agudu

Abuja, Federal Capital Territory, Nigeria

Location

Related Publications (13)

• Sam-Agudu NA, Cornelius LJ, Okundaye JN, Adeyemi OA, Isah HO, Wiwa OM, Adejuyigbe E, Galadanci H, Afe AJ, Jolaoso I, Bassey E, Charurat ME. The impact of mentor mother programs on PMTCT service uptake and retention-in-care at primary health care facilities in Nigeria: a prospective cohort study (MoMent Nigeria). J Acquir Immune Defic Syndr. 2014 Nov 1;67 Suppl 2:S132-8. doi: 10.1097/QAI.0000000000000331.

  PMID: 25310119 BACKGROUND

• Cataldo F, Sam-Agudu NA, Phiri S, Shumba B, Cornelius LJ, Foster G. The Roles of Expert Mothers Engaged in Prevention of Mother-to-Child Transmission (PMTCT) Programs: A Commentary on the INSPIRE Studies in Malawi, Nigeria, and Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S224-S232. doi: 10.1097/QAI.0000000000001375.

  PMID: 28498193 BACKGROUND

• Sam-Agudu NA, Aliyu MH, Adeyemi OA, Oronsaye F, Oyeledun B, Ogidi AG, Ezeanolue EE. Generating evidence for health policy in challenging settings: lessons learned from four prevention of mother-to-child transmission of HIV implementation research studies in Nigeria. Health Res Policy Syst. 2018 Apr 17;16(1):32. doi: 10.1186/s12961-018-0309-x.

  PMID: 29665809 BACKGROUND

• Al-Mujtaba M, Cornelius LJ, Galadanci H, Erekaha S, Okundaye JN, Adeyemi OA, Sam-Agudu NA. Evaluating Religious Influences on the Utilization of Maternal Health Services among Muslim and Christian Women in North-Central Nigeria. Biomed Res Int. 2016;2016:3645415. doi: 10.1155/2016/3645415. Epub 2016 Feb 24.

  PMID: 27006944 RESULT

• McCarthy E, Joseph J, Foster G, Mangwiro AZ, Mwapasa V, Oyeledun B, Phiri S, Sam-Agudu NA, Essajee S. Modeling the Impact of Retention Interventions on Mother-to-Child Transmission of HIV: Results From INSPIRE Studies in Malawi, Nigeria, and Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2(2):S233-S239. doi: 10.1097/QAI.0000000000001364.

  PMID: 28498194 RESULT

• Sam-Agudu NA, Ramadhani HO, Isah C, Erekaha S, Fan-Osuala C, Anaba U, Adejuyigbe EA, Charurat M. The Impact of Structured Mentor Mother Programs on Presentation for Early Infant Diagnosis Testing in Rural North-Central Nigeria: A Prospective Paired Cohort Study. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S182-S189. doi: 10.1097/QAI.0000000000001345.

  PMID: 28498188 RESULT

• Sam-Agudu NA, Ramadhani HO, Isah C, Anaba U, Erekaha S, Fan-Osuala C, Galadanci H, Charurat M. The Impact of Structured Mentor Mother Programs on 6-Month Postpartum Retention and Viral Suppression among HIV-Positive Women in Rural Nigeria: A Prospective Paired Cohort Study. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S173-S181. doi: 10.1097/QAI.0000000000001346.

  PMID: 28498187 RESULT

• Odiachi A, Erekaha S, Cornelius LJ, Isah C, Ramadhani HO, Rapoport L, Sam-Agudu NA. HIV status disclosure to male partners among rural Nigerian women along the prevention of mother-to-child transmission of HIV cascade: a mixed methods study. Reprod Health. 2018 Mar 2;15(1):36. doi: 10.1186/s12978-018-0474-y.

  PMID: 29499704 RESULT

• Cornelius LJ, Erekaha SC, Okundaye JN, Sam-Agudu NA. A Socio-Ecological Examination of Treatment Access, Uptake and Adherence Issues Encountered By HIV-Positive Women in Rural North-Central Nigeria. J Evid Inf Soc Work. 2018 Jan-Feb;15(1):38-51. doi: 10.1080/23761407.2017.1397580. Epub 2017 Dec 13.

  PMID: 29236624 RESULT

• Sam-Agudu NA, Isah C, Fan-Osuala C, Erekaha S, Ramadhani HO, Anaba U, Adeyemi OA, Manji-Obadiah G, Lee D, Cornelius LJ, Charurat M. Correlates of facility delivery for rural HIV-positive pregnant women enrolled in the MoMent Nigeria prospective cohort study. BMC Pregnancy Childbirth. 2017 Jul 14;17(1):227. doi: 10.1186/s12884-017-1417-2.

  PMID: 28705148 RESULT

• Sam-Agudu NA, Odiachi A, Bathnna MJ, Ekwueme CN, Nwanne G, Iwu EN, Cornelius LJ. "They do not see us as one of them": a qualitative exploration of mentor mothers' working relationships with healthcare workers in rural North-Central Nigeria. Hum Resour Health. 2018 Sep 10;16(1):47. doi: 10.1186/s12960-018-0313-9.

  PMID: 30200969 RESULT

• Odiachi A, Al-Mujtaba M, Torbunde N, Erekaha S, Afe AJ, Adejuyigbe E, Galadanci HS, Jasper TL, Cornelius LJ, Sam-Agudu NA. Acceptability of mentor mother peer support for women living with HIV in North-Central Nigeria: a qualitative study. BMC Pregnancy Childbirth. 2021 Aug 7;21(1):545. doi: 10.1186/s12884-021-04002-1.

  PMID: 34364384 DERIVED

• Odiachi A, Sam-Agudu NA, Erekaha S, Isah C, Ramadhani HO, Swomen HE, Charurat M, Cornelius LJ. A mixed-methods assessment of disclosure of HIV status among expert mothers living with HIV in rural Nigeria. PLoS One. 2020 Apr 30;15(4):e0232423. doi: 10.1371/journal.pone.0232423. eCollection 2020.

  PMID: 32353036 DERIVED

Study Officials

• Nadia A Sam-Agudu, MD, CTropMed

  Institute of Human Virology, Nigeria; University of Maryland School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Techical Advisor, Pediatric and Adolescent HIV

Model Details: This is a prospective paired cohort study

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: April 24, 2014
• Primary Completion: November 30, 2016
• Study Completion: November 1, 2017
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)