Alcohol Harm Reduction Intervention Among Female Sex Workers in Mombasa, Kenya

Alcohol Use and STI/HIV Infections, Domestic Violence Clinical Trial

Official title:

Alcohol Harm Reduction Intervention Among Female Sex Workers in Mombasa, Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756469
• Other study ID #: PHE#KE.09.0235
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: January 8, 2015
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2015
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: USAIDKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 818
• Est. completion date: November 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Use and STI/HIV Infections, Domestic Violence

Intervention

Behavioral:
• Behavioral Intervention for Alcohol Use
Behavioral Intervention for Alcohol Use

Locations

Country	Name	City	State
Kenya	FHI360	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol use and STI/HIV infection	Outcomes assessed at up to 12 months follow-ups	up to 12 months	No
Secondary	Condom use and sexual violence	Outcomes assessed at up to 12 months follow-ups	up to 12 months	No