The Impact of Mentor Mothers on PMTCT Service Outcomes in Nigeria

HIV Clinical Trial

— MoMent  

Official title:

The Impact of Mentor Mother Programmes on PMTCT Service Uptake and Retention at Primary Healthcare Facilities in Nigeria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936753
• Other study ID #: IHVN_WHO_PMTCT_MoMent
• Secondary ID: RPC531
• Status: Completed
• Phase: N/A
• Start date: April 24, 2014
• Est. completion date: November 1, 2017

Study information

• Verified date: September 2018
• Source: Institute of Human Virology, Nigeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Nigeria has had a national HIV/AIDS care and treatment program in place since 2003. Included in this national program are prevention programs; the largest of which is the prevention-of-mother-to-child transmission (PMTCT) program. Despite more than 10 yrs of providing PMTCT, Nigeria still has significant problems with uptake of, and retention in these services. Only 30% of HIV-positive pregnant women receive HIV drugs for both treatment and prophylaxis, and Nigeria has an estimated 41,000 new child infections annually, the highest of any country in the world.

Mentor Mothers (MM) are women living with HIV who are experienced users and navigators of HIV services, particularly PMTCT. Public health interventions engaging MM to support other HIV-positive women for linkage and retention in PMTCT and treatment services has been tested in South Africa, and has been adopted and applied in several other African countries. Similar MM programs have also been adopted and implemented in Nigeria since 2007; however, objective evaluations of MM impact on PMTCT service uptake and retention have not been performed to date.

While MM and similar peer support interventions have shown some success in other African countries, their implementation between and within countries has not been standardized. Incremental impact may be gained with more structured, objective-specific MM programming and service delivery.

The MoMent (MOther MENTor) is an implementation research study that is evaluating the impact of structured vs routine peer support on PMTCT outcomes in Nigeria, focusing on two North-Central states, the Federal Capital Territory and Nasarawa. The intervention consists of a simple but detailed standardized training curriculum for MMs coupled with daily MM supervision by dedicated personnel as well as standardized, user-friendly tools for both MMs and their supervisors to use for service delivery. These trained MM, along with trained MM Supervisors, form the basis of the Mentor Mother Intervention package. The choice of rural areas served by Primary Healthcare Centers is due to the fact that PMTCT coverage and uptake is lowest in these areas; the study sites are located in hard-to-reach-areas where a significant number of PMTCT-eligible clientele live.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: November 1, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Pregnant and HIV-positive

• 15 years of age and above

Exclusion Criteria:

• Working or ever worked as a Mentor Mother

• Presenting in labor

• Does not plan to continue receiving services at study site

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Trained Mentor Mother and Supervisor
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.

Locations

Country	Name	City	State
Nigeria	Nadia Sam-Agudu	Abuja	FCT

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Human Virology, Nigeria	Federal Ministry of Health, Nigeria, University of Maryland

Country where clinical trial is conducted

Nigeria, 

References & Publications (11)

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: — View Citation

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. — View Citation

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: 10.1 — View Citation

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 A — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 stu — View Citation

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 Hea — View Citation

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 P — View Citation

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 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Maternal viral suppression at 6 months postpartum	Proportion of HIV-positive mothers with undetectable viral load (<20 copies/ml), measured at 6 months postpartum.	6 months (169 to 197 days) post-delivery
Secondary	Proportion of infants HIV-positive at 2 and 6 months post-delivery.	All exposed infants who tested positive by DNA-PCR at 6 - 8 weeks of age and at 6 months are included in analysis for "early" MTCT and "late" MTCT, respectively. Any infants testing positive at first/early DNA PCR are excluded for testing at 6 months of age.	At 2 months (62 days) and at 6 months (197 days) post-delivery.
Secondary	Proportion of HIV-positive mothers retained in PMTCT care at 12 months post-delivery.	Maternal retention is determined by evaluating for at least 1 clinic visit made for each 30-day period for the first 360 days postpartum. The proportion of women making at least 6 of 12 monthly appointments are designated retained; this proportion is calculated for each study arm.	At 360 days (12 months) post-delivery