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
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
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
NCT ID
NCT02882607
First Posted
August 1, 2016
Last Updated
September 9, 2016
Sponsor
University of Illinois at Chicago
Collaborators
Kamuzu College of Nursing, University of Malawi
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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Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women
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