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Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women

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ClinicalTrials.gov Identifier: NCT02882607
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : September 12, 2016
Sponsor:
Collaborator:
Kamuzu College of Nursing, University of Malawi
Information provided by (Responsible Party):
Kathy Norr, University of Illinois at Chicago

Brief Summary:
The purpose of this study is to test the efficacy of an innovative, culturally relevant, community-based peer group intervention to increase young rural Malawian women's preconception behaviors to optimize their reproductive health. The study uses a longitudinal, two group (two-arm) design with a delayed control group.

Condition or disease Intervention/treatment Phase
HIV Pregnancy Sexually Transmitted Infections Behavioral: Mzanga Samala Moyo Wako ([Mzanga] Peer Groups Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women
Study Start Date : May 2009
Actual Primary Completion Date : July 2014
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention group
Reproductive Health Peer Groups
Behavioral: Mzanga Samala Moyo Wako ([Mzanga] 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

No Intervention: Control group
no intervention



Primary Outcome Measures :
  1. change in unprotected sex [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in having had an HIV test [ Time Frame: 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

  2. change in having sexually transmitted infection (STI) symptoms [ Time Frame: baseline to 15 months post-baseline ]
    change in reported STI symptoms between baseline and 9-month and 15-month survey

  3. Change in unintended pregnancy [ Time Frame: 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



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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02882607


Sponsors and Collaborators
University of Illinois at Chicago
Kamuzu College of Nursing, University of Malawi
Investigators
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Principal Investigator: Kathleen F. Norr, PhD University of Illinois at Chicago

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Responsible Party: Kathy Norr, Professor Emerita, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02882607     History of Changes
Other Study ID Numbers: R01HD060461 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deidentified data will be made available 5 yrs. after study completion by request to the PI

Keywords provided by Kathy Norr, University of Illinois at Chicago:
HIV
Prevention
unintended pregnancy
Malawi
adolescent women
community
rural

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female