Alcohol Harm Reduction Intervention Among Female Sex Workers in Mombasa, Kenya
Primary Purpose
Alcohol Use and STI/HIV Infections, Domestic Violence
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Behavioral Intervention for Alcohol Use
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Use and STI/HIV Infections, Domestic Violence
Eligibility Criteria
Inclusion Criteria:
- Female sex worker, defined as a woman who self reports exchange of any type of sex including oral, anal, and vaginal sex for money or gifts within the six months prior to study enrollment;
- Self-identifies as a woman;
- 18 years or older;
- Scores between 7-19 on the AUDIT questionnaire;
- Willing to participate in the study and all data collection procedures;
- Lives in Mombasa or plans on residing in Mombasa for 12 months following study enrollment;
- Currently participating in the APHIA II sex worker peer education program; and
- Documentation of negative tests for gonorrhea, Chlamydia, and trichomoniasis.
Exclusion Criteria:
- Scores less than 7 (low-risk drinking) or more than 19 (high-risk drinking/alcohol dependence) on the AUDIT questionnaire;
- Plans to be away in the next 12 months for more than six months or relocate away from the study site;
- Currently participating in another HIV intervention study; or
- Has any other condition that, in the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise with achieving the study objectives.
Sites / Locations
- FHI360
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Intervention
Arm Description
non-alcohol related information about nutrition
Behavioral Intervention for Alcohol Use
Outcomes
Primary Outcome Measures
Alcohol use and STI/HIV infection
Outcomes assessed at up to 12 months follow-ups
Secondary Outcome Measures
Condom use and sexual violence
Outcomes assessed at up to 12 months follow-ups
Full Information
NCT ID
NCT01756469
First Posted
December 20, 2012
Last Updated
January 8, 2015
Sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID)
1. Study Identification
Unique Protocol Identification Number
NCT01756469
Brief Title
Alcohol Harm Reduction Intervention Among Female Sex Workers in Mombasa, Kenya
Official Title
Alcohol Harm Reduction Intervention Among Female Sex Workers in Mombasa, Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main study objective is to investigate whether female sex workers (FSWs) at drop-in centers in Mombasa, Kenya, who report harmful or hazardous alcohol intake and participate in a brief alcohol intervention (vs. those who participate in a nutrition intervention in the control group), will reduce their alcohol use and incidence of STIs, HIV, and sexual violence, as well as increase their condom use.
Detailed Description
This is a longitudinal intervention study among female sex workers affiliated with the APHIA II program, who have harmful or hazardous alcohol use patterns. The purpose of the study is to obtain initial estimates of the impact of the intervention on alcohol use and STI acquisition, to help determine if this is a program that should be implemented more fully. Female sex workers will be recruited from three APHIA drop-in centers in Mombasa district, Kenya who serve more than 15,000 FSWs. Approximately 800 FSWs with harmful or hazardous alcohol use will be enrolled in the study over a six-month accrual period with a follow-up of 12 months for each participant. FSWs will be randomly assigned to either the intervention or "active" control arm. The intervention arm will receive the Brief Intervention for Alcohol Use (BI), which is designed for individuals with harmful or hazardous alcohol use, in addition to information about nutrition. The control arm will receive only non-alcohol related information about nutrition during the study period. A peer educator from the APHIA II project will inform potential participants about the study. A trained nurse counselor or research assistant will then screen interested volunteers for harmful alcohol use with the validated AUDIT questionnaire (WHO, 2001) and obtain informed consent from eligible participants. Arm assignment using random allocation will be made after volunteers are screened for eligibility, provide consent for participation, and complete baseline data collection procedures. Follow-up data collection will occur at six and twelve months post-randomization. Data collection procedures at all three time points will include the AUDIT questionnaire, a behavioral interview, a gynecological exam including STI diagnosis and treatment, and a HIV rapid test and counseling.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use and STI/HIV Infections, Domestic Violence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
818 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
non-alcohol related information about nutrition
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Behavioral Intervention for Alcohol Use
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention for Alcohol Use
Other Intervention Name(s)
BI
Intervention Description
Behavioral Intervention for Alcohol Use
Primary Outcome Measure Information:
Title
Alcohol use and STI/HIV infection
Description
Outcomes assessed at up to 12 months follow-ups
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Condom use and sexual violence
Description
Outcomes assessed at up to 12 months follow-ups
Time Frame
up to 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female sex worker, defined as a woman who self reports exchange of any type of sex including oral, anal, and vaginal sex for money or gifts within the six months prior to study enrollment;
Self-identifies as a woman;
18 years or older;
Scores between 7-19 on the AUDIT questionnaire;
Willing to participate in the study and all data collection procedures;
Lives in Mombasa or plans on residing in Mombasa for 12 months following study enrollment;
Currently participating in the APHIA II sex worker peer education program; and
Documentation of negative tests for gonorrhea, Chlamydia, and trichomoniasis.
Exclusion Criteria:
Scores less than 7 (low-risk drinking) or more than 19 (high-risk drinking/alcohol dependence) on the AUDIT questionnaire;
Plans to be away in the next 12 months for more than six months or relocate away from the study site;
Currently participating in another HIV intervention study; or
Has any other condition that, in the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise with achieving the study objectives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Mwarogo, MPH
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
Facility Information:
Facility Name
FHI360
City
Nairobi
Country
Kenya
12. IPD Sharing Statement
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Alcohol Harm Reduction Intervention Among Female Sex Workers in Mombasa, Kenya
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