The Impact of Mentor Mothers on PMTCT Service Outcomes in Nigeria (MoMent)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Institute of Human Virology, Nigeria
Sponsor:
Collaborators:
University of Maryland, Baltimore County
Clinton Health Access Initiative, Nigeria
Federal Ministry of Health, Nigeria
Information provided by (Responsible Party):
Dr. Nadia Sam-Agudu, Institute of Human Virology, Nigeria
ClinicalTrials.gov Identifier:
NCT01936753
First received: September 3, 2013
Last updated: April 28, 2015
Last verified: April 2015
  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

Resource links provided by NLM:


Further study details as provided by Institute of Human Virology, Nigeria:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 480
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Study Participant Inclusion Criteria:

  • Pregnant and HIV-positive
  • Accessing antenatal care at Primary Healthcare Facility participating in study
  • 15 years of age and above

Exclusion Criteria:

  • Working or ever worked as a Mentor Mother
  • Presenting in labor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936753

Contacts
Contact: Christopher Isah, HND, Nigeria potentialchris@yahoo.co.uk
Contact: Olusegun Adeyemi, MBBS, MPH sadeyemi@ihvnigeria.org

Locations
Nigeria
Institute of Human Virology, Nigeria Recruiting
Abuja, Federal Capital Territory, Nigeria
Principal Investigator: Nadia A Sam-Agudu, MD, CTropMed         
Sub-Investigator: Ebun Adejuyigbe, MBBS         
Sub-Investigator: Hadiza Galadanci, MBBS, MSc         
Sub-Investigator: Deborah Bako, MBBS         
Sub-Investigator: Manhattan Charurat, PhD, MS         
Sub-Investigator: Llewellyn Cornelius, PhD         
Sub-Investigator: Joshua Okundaye, PhD         
Sub-Investigator: Joseph Afe, MBBS, MPH         
Sponsors and Collaborators
Institute of Human Virology, Nigeria
University of Maryland, Baltimore County
Clinton Health Access Initiative, Nigeria
Federal Ministry of Health, Nigeria
Investigators
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

Additional 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: April 28, 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 July 30, 2015