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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882607
• Other study ID #: R01HD060461
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: September 9, 2016
• Start date: May 2009
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMalawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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:

1. Practice safer sex,

2. Obtain prompt treatment for STI symptoms;

3. Maintain good health habits (diet, exercise, substance use);

4. Use an effective family planning method except when pregnancy is intended;

5. Have an HIV test periodically, with partner when conception is intended; and

6. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: April 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Pregnancy
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Kamuzu College of Nursing, University of Malawi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to 15 months post-baseline	No
Secondary	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 had an HIV test from baseline to 15 months post-baseline	No
Secondary	change in having sexually transmitted infection (STI) symptoms	change in reported STI symptoms between baseline and 9-month and 15-month survey	baseline to 15 months post-baseline	No
Secondary	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	Change in unintended pregnancy from baseline to 15 months post-intervention	No