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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01756469
First received: December 20, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Alcohol Use and STI/HIV Infections, Domestic Violence
Behavioral: Behavioral Intervention for Alcohol Use

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Alcohol Harm Reduction Intervention Among Female Sex Workers in Mombasa, Kenya

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Alcohol use and STI/HIV infection [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Outcomes assessed at up to 12 months follow-ups


Secondary Outcome Measures:
  • Condom use and sexual violence [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Outcomes assessed at up to 12 months follow-ups


Enrollment: 818
Study Start Date: March 2011
Estimated Study Completion Date: October 2015
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
non-alcohol related information about nutrition
Active Comparator: Intervention
Behavioral Intervention for Alcohol Use
Behavioral: Behavioral Intervention for Alcohol Use
Behavioral Intervention for Alcohol Use
Other Name: BI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756469

Locations
Kenya
FHI360
Nairobi, Kenya
Sponsors and Collaborators
FHI 360
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Peter Mwarogo, MPH FHI 360
  More Information

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01756469     History of Changes
Other Study ID Numbers: PHE#KE.09.0235
Study First Received: December 20, 2012
Last Updated: March 25, 2014
Health Authority: United States: USAID
Kenya: Ethical Review Committee

Additional relevant MeSH terms:
Alcohol Drinking
Ethanol
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014