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Risk Reduction BehaviorPhase 1FASYNCT01492829

A Community-health Worker Delivered HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti

A Phase 1 study testing individual and group-based, community health worker delivered in people with Risk Reduction Behavior and Interpersonal Relations, run by Women's College Hospital at 1 site in Haiti.

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 investigators will develop, deliver and evaluate a solar powered tablet-based individual and group focused HIV/STI prevention intervention with internally displaced women in Leogane, Haiti. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
individual and group-based, community health worker delivered
How many people
200 participants
Where
1 siteHaiti
Study dates
Jan 2012to Jul 2012
Phase
Phase 1
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 and over
  • capable of providing informed consent
  • internally displaced (living in tent or camp)
  • female

Who cannot join

  • male
  • under 18 years old
  • not able to provide informed consent

Trial locations and contacts

1 site in 1 country.

Haiti1 site

  • NEGES

    Léogâne

Other trials in Haiti

About this study

Official title: Development and Evaluation of a Community Health Worker Delivered HIV/STI Prevention Intervention for Women Living in Internally Displaced Persons Camps in Leogane, Haiti

The investigators will develop, deliver and evaluate a solar powered tablet-based individual and group focused HIV/STI prevention intervention with internally displaced women in Leogane, Haiti. Internally displaced women will be trained as community health workers to deliver the HIV/STI prevention intervention to other internally displaced women.

Read the detailed description

We will develop and field test a multi-component intervention that includes (1) solar-powered tablets with brief video-based educational messages and (2) 6 weekly peer-group sessions. The tablet will be programmed to analyze the data and to indicate incorrect HIV knowledge responses so the community health worker can immediately provide correct responses. This intervention involves 6 weekly women's health meetings that will cover a variety of issues pertinent to women's sexual health: HIV/AIDS, sexually transmitted infections, interpersonal relationships, communication and decision making, mental health and coping, creating social change.

Being tested
individual and group-based, community health worker delivered
Keywords
HIV prevention, sexually transmitted infection prevention, HIV knowledge, relationship power, depression, coping, social support, internally displaced persons, community health worker, HIV/STI educational video, substance use, women's health
Medical subject headings
Risk Reduction Behavior, Mental Disorders, Depression, Substance-Related Disorders

What participants receive

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

  • individual and group-based, community health worker deliveredBehavioural

    Pre-test will be individual, tablet-based; participants will receive correct information for incorrect HIV/STI knowledge responses and will watch a brief HIV/STI educational video. This will be followed by participants attending 6 weeks of group educational sessions focused on: HIV, STI, interpersonal relationships, communication and decision-making, mental health and coping, creating social change

What is being measured

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

  1. HIV Knowledge

    Brief HIV Knowledge Questionnaire (Carey \& Schroder, 2002)

    Measured: 8 weeks

Secondary outcomes (7)

  1. Sexually Transmitted Infection Knowledge

    Measured using Sexually Transmitted Disease Knowledge Questionnaire (Jaworski \& Carey, 2007)

    Measured: 8 weeks

  2. Condom use

    Measured using a self-report of frequency of condom use with regular, casual and paid sex sexual partners

    Measured: 8 weeks

  3. Substance use

    Measured using self-reported frequency of drug/alcohol use

    Measured: 8 weeks

  4. Depression

    Measured using Patient Health Questionnaire 2 (PHQ-2)

    Measured: 8 weeks

  5. Social support

    Measured using Multi-dimensional scale of perceived social support (Zimet et al., 1988)

    Measured: 8 weeks

  6. resilient coping

    Measured using Brief Resilient Coping Scale (Sinclair \& Wallston, 2004)

    Measured: 8 weeks

  7. Relationship Control

    Sexual Relationship Power Scale (Pulerwitz, Gortmaker \& DeJong, 2000)

    Measured: 8 weeks

Timeline

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

  1. First posted15 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJun 2012
  4. Study completionJul 2012

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 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492829
Sponsor's protocol ID
GCC#0016-01-04-01-01
Acronym
FASY
Status last verified
Feb 2013
First submitted
13 Dec 2011
Last updated
20 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • Logie CH, Daniel C, Wang Y. Factors associated with consistent condom use among internally displaced women in Leogane, Haiti: results from a cross-sectional tablet-based survey. Sex Transm Infect. 2016 Nov;92(7):520-524. doi: 10.1136/sextrans-2015-052400. Epub 2016 Mar 31.

    PubMed 27034426

  • Logie CH, Daniel C, Newman PA, Weaver J, Loutfy MR. A psycho-educational HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: results from a non-randomized cohort pilot study. PLoS One. 2014 Feb 28;9(2):e89836. doi: 10.1371/journal.pone.0089836. eCollection 2014.

    PubMed 24587068

  • Logie CH, Daniel C, Newman PA, Loutfy MR. An HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: study protocol for an N-of-1 pilot study. BMJ Open. 2012 Jul 18;2(4):e001634. doi: 10.1136/bmjopen-2012-001634. Print 2012.

    PubMed 22815471

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing individual and group-based, community health worker delivered in people with Risk Reduction Behavior and Interpersonal Relations, run by Women's College Hospital at 1 site in Haiti.

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 4 inclusion and 3 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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

HIV Knowledge (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492829, which also lists 3 linked publications.

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 20 Feb 2013.

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