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HIVNCT02882607

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

A study testing Mzanga Samala Moyo Wako ([Mzanga] Peer Groups in people with HIV and Pregnancy, run by University of Illinois Chicago.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 20 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV, Pregnancy, Sexually Transmitted Infections
What is being tested?
Mzanga Samala Moyo Wako ([Mzanga] Peer Groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
810 participants
Where
No sites listed yet
Study dates
May 2009to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 20 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • lives in designated community

Who cannot join

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

About this study

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.

Read the 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:

  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.

Being tested
Mzanga Samala Moyo Wako ([Mzanga] Peer Groups
Keywords
HIV, Prevention, unintended pregnancy, Malawi, adolescent women, community, rural
Medical subject headings
Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mzanga Samala Moyo Wako ([Mzanga] Peer GroupsBehavioural

    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

Study groups in NCT02882607
Study groupRoleWhat they receive
Intervention groupExperimentalReproductive Health Peer Groups
Receives: Behavioral: Mzanga Samala Moyo Wako ([Mzanga] Peer Groups
Control groupNo interventionno intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline to 15 months post-baseline

Secondary outcomes (3)
  1. 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

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

  2. change in having sexually transmitted infection (STI) symptoms

    change in reported STI symptoms between baseline and 9-month and 15-month survey

    Measured: baseline to 15 months post-baseline

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study startMay 2009
  3. Primary completionJul 2014
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
810 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02882607
Sponsor's protocol ID
R01HD060461
Status last verified
Sep 2016
First submitted
1 Aug 2016
Last updated
12 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Deidentified data will be made available 5 yrs. after study completion by request to the PI

Questions about this trial

What is this clinical trial studying?

A study testing Mzanga Samala Moyo Wako ([Mzanga] Peer Groups in people with HIV and Pregnancy, run by University of Illinois Chicago.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in unprotected sex (time frame: Change from baseline to 15 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.

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