The Impact of Mentor Mothers on PMTCT Service Outcomes in Nigeria (MoMent)
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Purpose
Nigeria has significant challenges in the delivery and coverage of PMTCT (Prevention of mother-to-child transmission of HIV) services. Only 20 to 30% of pregnant women living with HIV are provided anti-retroviral drugs for PMTCT. Only 4% 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, almost 30%.
The investigators expect that Mentor Mothers (women living with HIV who serve as peer counselors) will help to improve uptake and successful completion of PMTCT services (eg testing and appointments), for reduced MTCT rates. The investigators also expect Mentor Mothers to have a positive effect on other outcomes for mothers and babies in PMTCT programs, for example, general health, breastfeeding rates, facility deliveries, and maternal-infant survival.
| Condition | Intervention |
|---|---|
|
HIV |
Behavioral: Trained Mentor Mother and Supervisor |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Impact of Mentor Mother Programmes on PMTCT Service Uptake and Retention at Primary Healthcare Facilities in Nigeria |
- Proportion of HIV-exposed infants receiving DNA PCR test by 2 months of age. [ Time Frame: When HIV-exposed infant is between 6 weeks and 2 months old. ] [ Designated as safety issue: No ]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.
- Proportion of mothers and exposed infants retained in PMTCT program at 6 months post-delivery. [ Time Frame: From delivery date to 6 months post-delivery ] [ Designated as safety issue: No ]PMTCT program retention for mothers and exposed babies will be determined using number of attended and missed appointments out of the expected postpartum visits. The proportion of Mother-Infant Pairs who are retained at 6 months post-delivery will be calculated.
- Proportion of mothers ART-adherent pre- and post-delivery [ Time Frame: From study enrollment at ANC clinic to delivery (predelivery) and from time of delivery to 6 months post-delivery ] [ Designated as safety issue: No ]Pre-delivery ART adherence will be assessed by pharmacy refills/drug pickups; post-delivery adherence will be assessed by a single 6 month postpartum maternal viral load.
- Proportion of infants HIV-positive at initial and 6 months post-delivery. [ Time Frame: At first DNA-PCR by 6-8 weeks of age and at 6 months post-delivery. ] [ Designated as safety issue: No ]All exposed infants who got tested initially by DNA-PCR, at 6 - 8 weeks of age will have their results review for assessment of early MTCT rate and at 6 month post-delivery for late MTCT rate.
- Proportion of mothers and exposed infants retained in PMTCT program at 12 months post-delivery. [ Time Frame: From time of delivery to 12 months post-partum. ] [ Designated as safety issue: No ]PMTCT program retention for mothers and exposed babies will be determined using number of attended and missed appointments out of the expected postpartum visits. The proportion of Mother-Infant Pairs who are retained at 12 months post-delivery will be calculated.
| Enrollment: | 492 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Trained Mentor Mother and Supervisor
Mentor Mothers trained by a standard study curriculum are assigned to pregnant HIV-positive women accessing care at Primary Healthcare Centers in study communities. Under close outcomes-focused supervision, Mentor Mothers provide psychosocial/drug adherence/appointment support and counseling for the mother-infant pair 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
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: Control
Pregnant HIV-positive women receive standard-of-care PMTCT services (drugs, appointments, tests). These women are assigned peer counselors who are also HIV-positive women with PMTCT experience but who do not receive standardized/any formal training, and are not closely supervised.
|
Detailed Description:
Nigeria has had a national HIV/AIDS care and treatment program in place since 2003. Included in this national program are preventive sub-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. These problems translate into only 20 to 30% of HIV-positive pregnant women receiving Anti-Retroviral Drug (ARV) prophylaxis, and the highest number of new child HIV infections in any country in the world.
Mentor Mothers (MM) are women living with HIV who are experienced users and navigators of HIV service delivery, particularly PMTCT. The idea to employ these women's experience in bringing other HIV-positive (especially pregnant) women into HIV care and PMTCT services has been tested in South Africa, and has been adopted and applied in several other African countries. MM programs have also been adopted and utilized in Nigeria, especially by the Institute of Human Virology Nigeria (IHVN); however, objective measurements of MM impact on PMTCT service uptake and retention have not been carried out in Nigeria.
The investigators are conducting an impact evaluation study of MM in Nigeria, focusing on two North-Central states, the Federal Capital Territory and Nasarawa. This study is dubbed MoMent (Mother Mentor) study.The research team has specifically developed a rigorous, yet trainee-appropriate, standardized training curriculum for MoMent study MM. These trained MM, along with trained MM Supervisors, form the basis of our "Mentor Mother Intervention package". The choice of Primary Healthcare Facilities for this study are due to the fact that they are located in areas where PMTCT coverage and uptake is often lowest; they sites are located in hard-to-reach-areas where a significant number of PMTCT-eligible clientele live. The investigators expect the roll-out of the Mentor Mother Intervention package to improve visibility/acceptability of, access to, and retention in PMTCT services in rural areas.
Eligibility| Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Study Participant 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01936753
| Nigeria | |
| Institute of Human Virology, Nigeria | |
| Abuja, Federal Capital Territory, Nigeria | |
| Principal Investigator: | Nadia A Sam-Agudu, MD, CTropMed | Institute of Human Virology, Nigeria; University of Maryland Baltimore |
| Study Director: | Olusegun Adeyemi, MBBS, MPH | Institute of Human Virology, Nigeria |
More Information
Publications:
| Responsible Party: | Dr. Nadia Sam-Agudu, Techical Advisor, Pediatric HIV Program, Institute of Human Virology, Nigeria |
| ClinicalTrials.gov Identifier: | NCT01936753 History of Changes |
| Other Study ID Numbers: | IHVN_WHO_PMTCT_MoMent RPC531 |
| Study First Received: | September 3, 2013 |
| Last Updated: | September 15, 2015 |
| Health Authority: | Nigeria: Federal Ministry of Health |
Keywords provided by Institute of Human Virology, Nigeria:
|
PMTCT HIV Mentor Mothers |
Nigeria Retention Adherence |
ClinicalTrials.gov processed this record on September 26, 2016