Clinical trial NCT01492829: A Community-health Worker Delivered HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Risk Reduction Behavior
Interpersonal Relations
Mental Disorders
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
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: NEGES Foundation, Leogane, Haiti
name: Adelphi University
First posted: 2011-12-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. Internally displaced women will be trained as community health workers to deliver the HIV/STI prevention intervention to other internally displaced women.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: HIV Knowledge
timeFrame: 8 weeks
Secondary outcomes:
measure: Sexually Transmitted Infection Knowledge
timeFrame: 8 weeks
measure: Condom use
timeFrame: 8 weeks
measure: Substance use
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
measure: Social support
timeFrame: 8 weeks
measure: resilient coping
timeFrame: 8 weeks
measure: Relationship Control
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Leogane
country: Haiti
facility: NEGES
Study officials:
affiliation: Women's College Hospital
name: Carmen H Logie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.