ClinicalTrials.gov
ClinicalTrials.gov Menu

MAMAS: Mentoring Adolescent Mothers at School (MAMAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03090802
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborators:
University of KwaZulu
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Drexel University

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


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Herpes Simplex Type II Chlamydia Gonorrhea Trichomonas Vaginitis Behavioral: Mentoring Adolescent Mothers at School (MAMAS) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Re-enrolling Young South African Mothers in School as a Social Vaccine Against HIV Transmission
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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)
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.

No Intervention: Control
Adolescent mothers in the control arm will receive adolescent-friendly clinical care from 2 weeks-9 months postpartum.



Primary Outcome Measures :
  1. Self-reported enrollment into school [ Time Frame: 9-months postpartum ]
    Binary outcome

  2. Self-report missed days in school in the past 30 days [ Time Frame: 9-months postpartum ]
    Categorical outcome (5)

  3. Self-reported number of men a participant has had sex with in the past 30 days [ Time Frame: 9-months postpartum ]
  4. Self-reported percentage of condom use while having sex in the past 30 days [ Time Frame: 9-months postpartum ]
    Categorical outcome (6)

  5. IPV in the last 30 days (WHO modified conflict tactic scale) [ Time Frame: 9-months postpartum ]
    Consist of 10-items.

  6. Results from HIV rapid test [ Time Frame: 9-months postpartum ]
    Binary outcome

  7. Results from Gonorrhea test using BD ProbeTec ET Amplified DNA Assay [ Time Frame: 9-months postpartum ]
    Binary outcome

  8. Results from Chlamydia test using BD ProbeTec ET Amplified DNA Assay [ Time Frame: 9-months postpartum ]
    Binary outcome

  9. Results from Trichomonas vaginalis test using in-house PCR [ Time Frame: 9-months postpartum ]
    Binary outcome


Secondary Outcome Measures :
  1. Score on peer support scale (self-reported) [ Time Frame: 9-months postpartum ]
    Consist of 7 items. Each item scored on 4 point scale.

  2. Score on familial support scale (self-reported) [ Time Frame: 9-months postpartum ]
    Consist of 7 items. Each item scored on 4 point scale.

  3. Whether participant applied for child support grant (self-reported) [ Time Frame: 9-months postpartum ]
    Binary outcome

  4. Whether participant received the child support grant (self-reported) [ Time Frame: 9-months postpartum ]
    Binary outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090802


Contacts
Contact: Allison K Groves, PhD, MHS 267-359-6274 aligroves@drexel.edu
Contact: Luwam T Gebrekristos, MPH lg526@drexel.edu

Locations
South Africa
Philasende Clinic Recruiting
Umlazi, South Africa
Contact: Dhayendre Moodley         
Sponsors and Collaborators
Drexel University
University of KwaZulu
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Allison K Groves, PhD, MHS Drexel University

Publications:
Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03090802     History of Changes
Other Study ID Numbers: 1612005048
S-LMAQM-16-CA-1103 ( Other Grant/Funding Number: U.S. Department of State )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Persons requesting permission to access non-biological data (behavioral assessments) will communicate with the project PI, Dr. Ali Groves, who will provide/decline permission. Persons requesting permission to access biological data (biological assessments and specimens) will communicate with the site PI, Dr. Daya Moodley, who will provide/decline permission. If permission is granted, the relevant research staff will be alerted to the release of samples/data as requested. A list of the participant samples/data being released will be provided to the PI, and the person requesting the data. Both will acknowledge release and receipt of samples/data. Data that will be provided with the samples will be limited to demographic data, no personal participant information will be provided; only participant identifiers will be used to identify the specific sample/data requested.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Drexel University:
Human Immunodeficiency Virus
resilience
adolescent mothers
Sub-Saharan Africa
intimate partner violence
postpartum period

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Herpes Simplex
Gonorrhea
Vaginitis
Trichomonas Infections
Trichomonas Vaginitis
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Genital Diseases, Male
Genital Diseases, Female
Vaginal Diseases
Protozoan Infections