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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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:
- 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.
- Conditions
- HIV, Pregnancy, Sexually Transmitted Infections
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Reproductive Health Peer Groups Receives: Behavioral: Mzanga Samala Moyo Wako ([Mzanga] Peer Groups |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted30 Aug 2016 (estimated)
- Study startMay 2009
- Primary completionJul 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Principal investigator, Kathy Norr, University of Illinois Chicago
- Investigators
- Kathleen F. Norr, PhD, Principal investigator, University of Illinois Chicago
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Groups for Healthy Pregnancy & HIV Prevention for Young Malawian Women
- ClinicalTrials.gov ID
- NCT02882607
- Acronym / sponsor ID
- R01HD060461
- Conditions
- HIV, Pregnancy, Sexually Transmitted Infections
- Keywords
- HIV, Prevention, unintended pregnancy, Malawi, adolescent women, community, rural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- May 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mzanga Samala Moyo Wako ([Mzanga] Peer GroupsReproductive Health Peer Groups |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- lives in designated community
Key exclusion criteria (1 listed)
- cognitive or other condition that makes the participant unable to converse in a group or answer questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mzanga Samala Moyo Wako ([Mzanga] Peer Groups8 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 | Behavioural | Intervention group |
Primary outcome
change in unprotected sex
Time frame: Change from baseline to 15 months post-baseline
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.
3 secondary outcomes
Change in having had an HIV test
Time frame: Change in having had an HIV test from baseline to 15 months post-baseline
change in having sexually transmitted infection (STI) symptoms
Time frame: baseline to 15 months post-baseline
Change in unintended pregnancy
Time frame: Change in unintended pregnancy from baseline to 15 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Individual participant dataSharing planned: No. Deidentified data will be made available 5 yrs. after study completion by request to the PI
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen F. Norr, PhD principal investigator
University of Illinois Chicago
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.