Overview

This trial is active, not recruiting.

Condition hiv
Treatment trained mentor mother and supervisor
Sponsor Institute of Human Virology, Nigeria
Collaborator University of Maryland
Start date September 2012
End date November 2016
Trial size 497 participants
Trial identifier NCT01936753, IHVN_WHO_PMTCT_MoMent, RPC531

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Intervention model description this is a prospective paired cohort study
Primary purpose prevention
Masking no masking
Arm
(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.
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.
(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.

Primary Outcomes

Measure
Proportion of HIV-exposed infants presenting for DNA PCR testing by 2 months of age.
time frame: 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.
time frame: At 180 days (6 months) post-delivery

Secondary Outcomes

Measure
Maternal viral suppression at 6 months postpartum
time frame: 6 months (169 to 197 days) post-delivery
Proportion of infants HIV-positive at 2 and 6 months post-delivery.
time frame: 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.
time frame: At 360 days (12 months) post-delivery

Eligibility Criteria

Female participants at least 15 years old.

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

Additional Information

Official title The Impact of Mentor Mother Programmes on PMTCT Service Uptake and Retention at Primary Healthcare Facilities in Nigeria
Principal investigator Nadia A Sam-Agudu, MD, CTropMed
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Institute of Human Virology, Nigeria.