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

Primary Purpose

HIV, Pregnancy, Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mzanga Samala Moyo Wako ([Mzanga] Peer Groups
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, Prevention, unintended pregnancy, Malawi, adolescent women, community, rural

Eligibility Criteria

15 Years - 20 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    Reproductive Health Peer Groups

    no intervention

    Outcomes

    Primary Outcome Measures

    change in unprotected sex
    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

    Change in having had an HIV test
    change in whether had a recent HIV test (within the last 12 months) from baseline to 15-months post-baseline
    change in having sexually transmitted infection (STI) symptoms
    change in reported STI symptoms between baseline and 9-month and 15-month survey
    Change in unintended pregnancy
    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

    Full Information

    First Posted
    August 1, 2016
    Last Updated
    September 9, 2016
    Sponsor
    University of Illinois at Chicago
    Collaborators
    Kamuzu College of Nursing, University of Malawi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02882607
    Brief Title
    Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women
    Official Title
    Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago
    Collaborators
    Kamuzu College of Nursing, University of Malawi

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV, Pregnancy, Sexually Transmitted Infections
    Keywords
    HIV, Prevention, unintended pregnancy, Malawi, adolescent women, community, rural

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    810 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Reproductive Health Peer Groups
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    no intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mzanga Samala Moyo Wako ([Mzanga] Peer Groups
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    change in unprotected sex
    Description
    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.
    Time Frame
    Change from baseline to 15 months post-baseline
    Secondary Outcome Measure Information:
    Title
    Change in having had an HIV test
    Description
    change in whether had a recent HIV test (within the last 12 months) from baseline to 15-months post-baseline
    Time Frame
    Change in having had an HIV test from baseline to 15 months post-baseline
    Title
    change in having sexually transmitted infection (STI) symptoms
    Description
    change in reported STI symptoms between baseline and 9-month and 15-month survey
    Time Frame
    baseline to 15 months post-baseline
    Title
    Change in unintended pregnancy
    Description
    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
    Time Frame
    Change in unintended pregnancy from baseline to 15 months post-intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kathleen F. Norr, PhD
    Organizational Affiliation
    University of Illinois at Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Deidentified data will be made available 5 yrs. after study completion by request to the PI

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