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

September 3, 2013
April 28, 2015
September 2012
December 2015   (final data collection date for primary outcome measure)
  • 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 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.
Complete list of historical versions of study NCT01936753 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
The Impact of Mentor Mothers on PMTCT Service Outcomes in Nigeria
The Impact of Mentor Mother Programmes on PMTCT Service Uptake and Retention at Primary Healthcare Facilities in Nigeria

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
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.
  • 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.
    Intervention: Behavioral: Trained Mentor Mother and Supervisor
  • 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.
Sam-Agudu NA, Cornelius LJ, Okundaye JN, Adeyemi OA, Isah HO, Wiwa OM, Adejuyigbe E, Galadanci H, Afe AJ, Jolaoso I, Bassey E, Charurat ME. The impact of mentor mother programs on PMTCT service uptake and retention-in-care at primary health care facilities in Nigeria: a prospective cohort study (MoMent Nigeria). J Acquir Immune Defic Syndr. 2014 Nov 1;67 Suppl 2:S132-8. doi: 10.1097/QAI.0000000000000331.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Female
15 Years and older
No
Contact: Christopher Isah, HND, Nigeria potentialchris@yahoo.co.uk
Contact: Olusegun Adeyemi, MBBS, MPH sadeyemi@ihvnigeria.org
Nigeria
 
NCT01936753
IHVN_WHO_PMTCT_MoMent, RPC531
No
Dr. Nadia Sam-Agudu, Institute of Human Virology, Nigeria
Institute of Human Virology, Nigeria
  • University of Maryland, Baltimore County
  • Clinton Health Access Initiative, Nigeria
  • Federal Ministry of Health, 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
Institute of Human Virology, Nigeria
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP