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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Maryland
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: March 22, 2017
Last verified: March 2017

September 3, 2013
March 22, 2017
September 2012
November 2016   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Proportion of HIV-exposed infants receiving DNA PCR test as early infant HIV diagnostic. [ Time Frame: When HIV-exposed infant is 2 months old ]
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
  • 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.
  • 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.
  • 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.
  • 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) ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a prospective paired cohort study
Masking: No masking
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: Mentor Mother Peer Support
    This is an enhanced behavioral intervention. Mentor Mothers trained with a standard study curriculum are assigned to pregnant HIV-positive women accessing care at Primary Healthcare Centers in study communities. Under close daily supervision, Mentor Mothers provide support and counseling for the mother-infant pairs 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: Routine Peer Support
    Pregnant HIV-positive women receive standard-of-care PMTCT services (drugs, appointments, tests). These women are, per routine, assigned peer counselors who are also HIV-positive women with PMTCT experience but who do receive little or no standardized formal training, and are not closely supervised.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
497
June 2017
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only HIV-positive pregnant females are eligible for recruitment. All infants born live to these females are also enrolled.
15 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Nigeria
 
 
NCT01936753
IHVN_WHO_PMTCT_MoMent
RPC531 ( Other Grant/Funding Number: World Health Organization )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Dr. Nadia Sam-Agudu, Institute of Human Virology, Nigeria
Institute of Human Virology, Nigeria
  • University of Maryland
  • Federal Ministry of Health, Nigeria
Principal Investigator: Nadia A Sam-Agudu, MD, CTropMed Institute of Human Virology, Nigeria; University of Maryland School of Medicine
Institute of Human Virology, Nigeria
March 2017

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