- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02882607
Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Maintaining optimal reproductive health in the context of high HIV prevalence is a serious dilemma facing young women in Malawi and other high HIV prevalence countries. Optimal reproductive health requires practicing preconception behaviors to promote overall health including avoiding HIV infection. These healthy preconception behaviors include: practicing safer sex (abstaining or using condoms) to prevent sexually transmitted infections (STIs), including HIV infection; obtaining treatment for STIs; maintaining good health habits such as diet, exercise and avoiding substance use; using an effective family planning method to prevent unintended pregnancy; and having an HIV test periodically and with the partner when conception is intended. However the Malawi Demographic and Health Survey provides evidence that few women ages 15-20 in Malawi currently practice these healthy preconception behaviors. Currently, no programs in Malawi offer an integrated approach to optimal reproductive health.
To fill this gap, this study developed an innovative, culturally relevant, community-based peer group intervention to increase young rural Malawian women's preconception behaviors to optimize their reproductive health. The intervention is called Mzanga Samala Moyo Wako ([Mzanga] Sharing Responsibility for Pregnancy Planning and HIV Prevention). Mzanga builds on the investigators' previous research in Malawi, which tested a culturally relevant HIV prevention peer group intervention that changed HIV prevention-related knowledge, attitudes, and safer sex behaviors for rural adults and adolescents. This study integrated that prior HIV prevention content with new content on maintaining health, family planning, and preconception HIV testing.
The purpose of this study is to test Mzanga's efficacy using a longitudinal, two group (two arm) design: intervention group and delayed control group. Because Mzanga is expected to diffuse widely, we randomize at the community rather than the individual level. Eighteen geographically separate rural communities stratified by size and distance from the main paved road and then randomly assigned to Mzanga or the delayed control condition. We implement Mzanga in 9 waves. A final sample of 345 per group after attrition provides adequate power (80%) to detect small-to-medium effects. After baseline data collection, the Mzanga group receives the eight-session intervention. Outcomes are measured at 9 months post-baseline (6 months post-intervention), followed by a booster session for the Mzanga group, and final evaluation at 15 months post-baseline. After the 15-month data collection, Mzanga is offered to the delayed control group.
The study aims and hypotheses are:
Aim 1. To test the efficacy of the Mzanga intervention for improving reproductive health outcome mediating and behavioral variables for Malawian rural young women at 9 and 15 months post-baseline.
H1.Controlling for baseline differences and group effects, compared to the delayed control group, the intervention group will show more positive mediating and behavioral outcomes:
- Practice safer sex,
- Obtain prompt treatment for STI symptoms;
- Maintain good health habits (diet, exercise, substance use);
- Use an effective family planning method except when pregnancy is intended;
- Have an HIV test periodically, with partner when conception is intended; and
- More positive scores for the mediating variables of knowledge, attitudes, perceived norms, self-efficacy, and intentions for each of these behaviors.
Aim 2. To test a theoretical model of the mechanisms through which the Mzanga intervention changes preconception health behaviors of young women in rural Malawi.
H2. Mzanga's effects on healthy preconception behaviors (a-e above) will be mediated by knowledge, attitudes, perceived norms, self-efficacy, and intention scores.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- lives in designated community
Exclusion Criteria:
- cognitive or other condition that makes the participant unable to converse in a group or answer questions
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Groupe de contrôle
aucune intervention
|
|
Expérimental: Intervention group
Reproductive Health Peer Groups
|
8 small group sessions led by community young women, focused on reproductive health, including HIV, STI and unintended pregnancy prevention; includes skill-building for self-efficacy
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
change in unprotected sex
Délai: Change from baseline to 15 months post-baseline
|
Change in having sex without a condom (n the last 2 months) from baseline to 15-months post-baseline, measured by 2 questions, have you had sex in the last 2 months, and (for those who had sex) have you used a condom 'always, sometimes or never'; if had sex and have not used a condom always are coded 'yes', had unprotected sex; all other responses are coded no.
|
Change from baseline to 15 months post-baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in having had an HIV test
Délai: Change in having had an HIV test from baseline to 15 months post-baseline
|
change in whether had a recent HIV test (within the last 12 months) from baseline to 15-months post-baseline
|
Change in having had an HIV test from baseline to 15 months post-baseline
|
change in having sexually transmitted infection (STI) symptoms
Délai: baseline to 15 months post-baseline
|
change in reported STI symptoms between baseline and 9-month and 15-month survey
|
baseline to 15 months post-baseline
|
Change in unintended pregnancy
Délai: Change in unintended pregnancy from baseline to 15 months post-intervention
|
Change in reported unintended pregnancy between baseline and 15-months post-baseline; measured by whether pregnant, confirmed visually and by pregnancy test, and whether reported in intending to become pregnant
|
Change in unintended pregnancy from baseline to 15 months post-intervention
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kathleen F. Norr, PhD, University of Illinois at Chicago
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01HD060461 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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