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

NCT02882607 | Completed

• 1 other identifier: R01HD060461
• Study Type: interventional
• Target: 810
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV; Pregnancy; Sexually Transmitted Infections

Keywords

HIV; Prevention; unintended pregnancy; Malawi; adolescent women; community; rural

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in having had an HIV test

  Change in having had an HIV test from baseline to 15 months post-baseline

• change in having sexually transmitted infection (STI) symptoms

  baseline to 15 months post-baseline

• Change in unintended pregnancy

  Change in unintended pregnancy from baseline to 15 months post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Reproductive Health Peer Groups

Behavioral: Mzanga Samala Moyo Wako ([Mzanga] Peer Groups

Control group

NO INTERVENTION

no intervention

Interventions

Mzanga Samala Moyo Wako ([Mzanga] Peer Groups BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• lives in designated community

You may not qualify if:

• cognitive or other condition that makes the participant unable to converse in a group or answer questions

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Kamuzu College of Nursing, University of Malawi: collaborator

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen F. Norr, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emerita

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 30, 2016
• Study Start: May 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: April 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share