MAMAS: Mentoring Adolescent Mothers at School

NCT03090802 | Completed

• 2 other identifiers: 1612005048S-LMAQM-16-CA-1103
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Immunodeficiency Virus; Herpes Simplex Type II; Chlamydia; Gonorrhea; Trichomonas Vaginitis

Keywords

Human Immunodeficiency Virus; resilience; adolescent mothers; Sub-Saharan Africa; intimate partner violence; postpartum period

Outcome Measures

Primary Outcomes (9)

• Self-reported enrollment into school

  Binary outcome

  9-months postpartum

• Self-report missed days in school in the past 30 days

  Categorical outcome (5)

  9-months postpartum

• Self-reported number of men a participant has had sex with in the past 30 days

  9-months postpartum

• Self-reported percentage of condom use while having sex in the past 30 days

  Categorical outcome (6)

  9-months postpartum

• IPV in the last 30 days (WHO modified conflict tactic scale)

  Consist of 10-items.

  9-months postpartum

• Results from HIV rapid test

  Binary outcome

  9-months postpartum

• Results from Gonorrhea test using BD ProbeTec ET Amplified DNA Assay

  Binary outcome

  9-months postpartum

• Results from Chlamydia test using BD ProbeTec ET Amplified DNA Assay

  Binary outcome

  9-months postpartum

• Results from Trichomonas vaginalis test using in-house PCR

  Binary outcome

  9-months postpartum

Secondary Outcomes (4)

• Score on peer support scale (self-reported)

  9-months postpartum

• Score on familial support scale (self-reported)

  9-months postpartum

• Whether participant applied for child support grant (self-reported)

  9-months postpartum

• Whether participant received the child support grant (self-reported)

  9-months postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

The participants of the program arm will have 15 group sessions with mentor mother and up to 2 home visits from 3 weeks-6 months postpartum, which is package as the Mentoring Adolescent Mothers at School (MAMAS) program. Further, adolescent mothers in the intervention arm will receive adolescent-friendly clinical care from 2 weeks-9 months postpartum.

Behavioral: Mentoring Adolescent Mothers at School (MAMAS)

Control

NO INTERVENTION

Adolescent mothers in the control arm will receive adolescent-friendly clinical care from 2 weeks-9 months postpartum.

Interventions

Mentoring Adolescent Mothers at School (MAMAS) BEHAVIORAL

Through the MAMAS program, 12 older mentor mothers, who themselves were pregnant adolescents, will mentor 240 younger adolescent mothers to provide ongoing psychosocial support, navigate re-admission to school, and facilitate access to an existing State-sponsored cash transfer, the child support grant (CSG), in the early postpartum period.

Intervention

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Given birth in the last two weeks
• 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

You may not qualify if:

• Not currently co-enrolled in other research programs
• Not interested in participating in the program

Sponsors & Collaborators

• Drexel University: lead
• University of KwaZulu: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Philasende Clinic

Umlazi, South Africa

Location

Related Publications (1)

• 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.

  PMID: 24824050 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Chlamydia Infections; Gonorrhea; Trichomonas Vaginitis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Allison K Groves, PhD, MHS

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 27, 2017
• Study Start: June 26, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)