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

17 septembre 2018 mis à jour par: Dr. Nadia Sam-Agudu, Institute of Human Virology, 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

497

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • FCT
      • Abuja, FCT, Nigeria
        • Nadia Sam-Agudu

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

15 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of HIV-exposed infants presenting for DNA PCR testing by 2 months of age.
Délai: 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.
At 2 months (62 days) of age for the HIV-exposed infant.
Proportion of HIV-positive mothers retained in PMTCT care at 6 months post-delivery.
Délai: 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.
At 180 days (6 months) post-delivery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Maternal viral suppression at 6 months postpartum
Délai: 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.
6 months (169 to 197 days) post-delivery
Proportion of infants HIV-positive at 2 and 6 months post-delivery.
Délai: 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.
At 2 months (62 days) and at 6 months (197 days) post-delivery.
Proportion of HIV-positive mothers retained in PMTCT care at 12 months post-delivery.
Délai: 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.
At 360 days (12 months) post-delivery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Nadia A Sam-Agudu, MD, CTropMed, Institute of Human Virology, Nigeria; University of Maryland School of Medicine

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 avril 2014

Achèvement primaire (Réel)

30 novembre 2016

Achèvement de l'étude (Réel)

1 novembre 2017

Dates d'inscription aux études

Première soumission

3 septembre 2013

Première soumission répondant aux critères de contrôle qualité

5 septembre 2013

Première publication (Estimation)

6 septembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 septembre 2018

Dernière vérification

1 septembre 2018

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • IHVN_WHO_PMTCT_MoMent
  • RPC531 (Autre subvention/numéro de financement: World Health Organization)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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