Human Immunodeficiency Virus Clinical Trial
— MAMASOfficial title:
Re-enrolling Young South African Mothers in School as a Social Vaccine Against HIV Transmission
Verified date | September 2021 |
Source | Drexel University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the efficacy of an intervention designed to reduce STI/HIV incidence by increasing the number of adolescent mothers who re-enroll and remain in school. The objective of the intervention is to have older mentor mothers, who themselves were pregnant adolescents, to mentor younger adolescent mothers. Mentor mothers will provide ongoing psychosocial support, help navigate re-admission to school, and help facilitate access to an existing State-sponsored cash transfer, the child support grant (CSG), in the early postpartum period. Our combination social protection program will enhance resilience of young adolescent mothers to facilitate their return to school and thereby reduce HIV risk. The investigators will evaluate the efficacy of the intervention using a pre-test post-test randomized controlled trial design. Participants in the intervention will receive the Mentoring Adolescent Mothers At School (MAMAS) intervention and standard postpartum care. Those in the control arm will receive standard postpartum care. Additionally, for those participants randomized to the intervention arm, mentor mothers will use participatory visual methods (e.g., photovoice, cell-films, drawings) as part of the intervention itself. Last, among those participants randomized to the intervention arm and who return for their 9-month assessment, the investigators will conduct 20 in-depth interviews to understand the process of resilience development from their perspective. Primary outcomes: School outcomes (initial outcomes) HYP 1.1: Program participation will increase school enrollment HYP 1.2: Program participation will increase school engagement HIV risk outcomes (intermediate outcomes) HYP 2.1: Program participation will reduce number of sexual partners HYP 2.2: Program participation will reduce inconsistent condom use HYP 2.3: Program participation will reduce intimate partner violence HYP 2.4: Program participation will decrease HIV/STI infection HYP 2.5 (for HIV+): Program participation will increase retention in care Secondary outcomes: HYP 5: Program participation will increase peer support HYP 6: Program participation will increase familial support HYP 7: Program participation will increase school re-admission HYP 8: Program participation will increase application to the child support grant HYP 9: Program participation will increase receipt of the child support grant
Status | Completed |
Enrollment | 152 |
Est. completion date | November 30, 2018 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 14 Years to 19 Years |
Eligibility | Inclusion criteria: - Given birth in the last two weeks - 14-19 years of age - Have been enrolled in school in Umlazi in the previous year - Planning to stay in the residential area for the next 9 months - Parent/guardian is willing and available to consent Exclusion criteria: - Not currently co-enrolled in other research programs - Not interested in participating in the program |
Country | Name | City | State |
---|---|---|---|
South Africa | Philasende Clinic | Umlazi |
Lead Sponsor | Collaborator |
---|---|
Drexel University | University of KwaZulu, University of North Carolina, Chapel Hill |
South Africa,
Maman S, Moodley D, McNaughton-Reyes HL, Groves AK, Kagee A, Moodley P. Efficacy of enhanced HIV counseling for risk reduction during pregnancy and in the postpartum period: a randomized controlled trial. PLoS One. 2014 May 13;9(5):e97092. doi: 10.1371/journal.pone.0097092. eCollection 2014. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported enrollment into school | Binary outcome | 9-months postpartum | |
Primary | Self-report missed days in school in the past 30 days | Categorical outcome (5) | 9-months postpartum | |
Primary | Self-reported number of men a participant has had sex with in the past 30 days | 9-months postpartum | ||
Primary | Self-reported percentage of condom use while having sex in the past 30 days | Categorical outcome (6) | 9-months postpartum | |
Primary | IPV in the last 30 days (WHO modified conflict tactic scale) | Consist of 10-items. | 9-months postpartum | |
Primary | Results from HIV rapid test | Binary outcome | 9-months postpartum | |
Primary | Results from Gonorrhea test using BD ProbeTec ET Amplified DNA Assay | Binary outcome | 9-months postpartum | |
Primary | Results from Chlamydia test using BD ProbeTec ET Amplified DNA Assay | Binary outcome | 9-months postpartum | |
Primary | Results from Trichomonas vaginalis test using in-house PCR | Binary outcome | 9-months postpartum | |
Secondary | Score on peer support scale (self-reported) | Consist of 7 items. Each item scored on 4 point scale. | 9-months postpartum | |
Secondary | Score on familial support scale (self-reported) | Consist of 7 items. Each item scored on 4 point scale. | 9-months postpartum | |
Secondary | Whether participant applied for child support grant (self-reported) | Binary outcome | 9-months postpartum | |
Secondary | Whether participant received the child support grant (self-reported) | Binary outcome | 9-months postpartum |
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