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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: September 5, 2013
Last verified: September 2013
  Purpose

Nigeria has much room to improve as far as the delivery and coverage of PMTCT (Prevention of mother-to-child transmission of HIV) services is concerned. A significant number of Nigerian women with HIV are not tested; similarly, an unacceptable number of women with HIV who are enrolled in PMTCT programs do not complete them. In other words, uptake and retention in PMTCT is not adequate.

The investigators expect that Mentor Mothers (women with HIV who act as peer counselors) will help to improve enrollment in, and successful completion of PMTCT services (eg testing and appointments). The investigators also expect Mentor Mothers to have a positive effect on outcomes for mothers and babies in the programs, for example, general and HIV-related health, HIV transmission rates, and survival.


Condition Intervention
HIV
Behavioral: Trained Mentor Mother

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 as early infant HIV diagnostic. [ Time Frame: When HIV-exposed infant is 2 months old ] [ Designated as safety issue: No ]
    Early infant diagnosis (EID) is defined as the performance 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 Highly Active Antiretroviral Therapy (HAART) in timely fashion. Late collection of DNA PCR for an HIV-exposed child may allow for late diagnosis of HIV, and delayed initiation of ART. This may lead to increased infant morbidity and mortality, which is undesirable in any PMTCT or Maternal Child Health program.


Secondary Outcome Measures:
  • Proportion of HIV+ mothers who were HAART-adherent during period of HAART eligibility. [ Time Frame: From study enrollment until end of breastfeeding period (or at end of study-when infant is 12 months old) ] [ Designated as safety issue: No ]
    We will measure proportion of HIV+ women who are > 95%, >80 to 95%, and < 80%-adherent during HAART eligibility periods pre- and post-delivery.

  • Proportion of exposed infants who complete 6 weeks of Nevirapine prophylaxis [ Time Frame: When exposed infant is 6 weeks of age ] [ Designated as safety issue: No ]
    In addition to starting early, successful Nevirapine prophylaxis also requires the completion of the recommended 6 week course.

  • Proportion of exposed infants who receive first dose of Nevirapine (NVP) syrup prophylaxis within 72 hrs of life [ Time Frame: When exposed infant is 72 hrs (3 days) old ] [ Designated as safety issue: No ]
    NVP, given as post-exposure prophylaxis to an exposed infant, is to be administered within 72 hrs. A delay in administering the first dose of NVP beyond 72 hrs may increase the risk of mother-to-child transmission of HIV.

  • Proportion of HIV+ mothers who exclusively breastfed for 6 months [ Time Frame: When exposed infant is 6 months old ] [ Designated as safety issue: No ]
    We will assess the proportion of HIV+ mothers who fed their infants breastmilk only, for the first 6 months. Mixed feeding (breastmilk with formula milk) poses a higher risk of mother-to-child-transmission of HIV.

  • Proportion of Mother-Infant Pairs who were retained in PMTCT services at 12 months postdelivery [ Time Frame: When exposed infant is 12 months old ] [ Designated as safety issue: No ]
    We will assess retention through appointments kept by the Mother-Infant Pair from time of delivery until 12 months postdelivery. A minimum of 6 appointments are expected, including the post-weaning test appointment for HIV-negative babies.

  • Proportion of HIV-exposed infants who received post-weaning HIV test [ Time Frame: 6 weeks postweaning; maximum 12 months + 6 weeks postdelivery ] [ Designated as safety issue: No ]
    All HIV-exposed infants who initially tested HIV negative at 6 weeks of age, and are still breastfeeding, will receive a second HIV test 6 weeks after weaning from breastmilk. The recommended time for complete weaning is 12 months of age, although some infants are weaned before this time. Making the appointment for this follow-up test is an important determinant of retention in PMTCT care for the mother-infant pair.


Estimated Enrollment: 480
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trained Mentor Mother
Mentor Mothers trained by a standard study curriculum are assigned to consenting pregnant HIV+ mothers accessing care at Primary Healthcare Centers in study communities. The 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
Trained Mentor Mothers provide psychosocial/drug adherence/appointment support and counseling for the mother-infant pair until the exposed infant is 12 months old. They support the mother-infant pair to achieve timely and complete access to, use of, and retention in PMTCT services along the entire cascade.
No Intervention: Control
Pregnant HIV+ women in this arm receive standard of care PMTCT services (drugs, appointments, tests) without the involvement of a trained Mentor Mother.

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 almost 10 yrs of providing PMTCT, Nigeria still has significant problems with uptake of, and retention in these services. These problems translate into only 10-20% of HIV+ pregnant women receiving Anti-Retroviral Drug (ARV) prophylaxis, and the highest pediatric HIV burden of 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+ (especially pregnant) women into HIV care and PMTCT services originated in South Africa, and has been adopted and applied in several African countries. MM programs have also been adopted and utilized in Nigeria, especially by the Institute of Human Virology Nigeria (IHVN); however, large studies and objective measurements of their 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. The research team has specifically developed a rigorous, yet trainee-appropriate, standardized training curriculum for MoMent study MM. The choice of Primary Healthcare Facilities in which to conduct this study is intentional; these sites are located in hard-to-reach-areas where a significant number of PMTCT-eligible clientele live. The investigators expect this strategy to improve visibility, acceptability, access and retention of 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+ at time of enrollment
  • 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
  • Previously or currently a recipient of Mentor Mother services
  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: Haroun Isah, MBBS, MPH         
Sub-Investigator: Owens Wiwa, MBBS, MPH         
Sub-Investigator: Ebun Adejuyigbe, MBBS         
Sub-Investigator: Emem Bassey, MBBS         
Sub-Investigator: Hadiza Galadanci, MBBS, MSc         
Sub-Investigator: Ibidun Jolaoso, RN         
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:
No publications provided

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 5, 2013
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 October 30, 2014