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Completed

NCT Number: NCT01936753

The Impact of Mentor Mothers on PMTCT Service Outcomes in Nigeria

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.

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Key information

Conditions

HIV

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nadia Sam-Agudu

Abuja, Federal Capital Territory, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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.

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

    Time frame: At 180 days (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.

Secondary outcomes

  1. Maternal viral suppression at 6 months postpartum

    Time frame: 6 months (169 to 197 days) post-delivery

    Proportion of HIV-positive mothers with undetectable viral load (<20 copies/ml), measured at 6 months postpartum.

  2. 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.

    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.

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

    Time frame: At 360 days (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.

Sponsors and collaborators

Lead sponsor

Institute of Human Virology, Nigeria

Other

Collaborators

  • Federal Ministry of Health, Nigeria
  • University of Maryland

Registry information

Official study title

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

Acronym: MoMent

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 6, 2013
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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