Evaluation of a Peer Education Program to Promote Family Planning Among Female Sex Workers in Kenya

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by FHI 360
Sponsor:
Collaborator:
Gold Star Kenya (GSKenya)
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01957813
First received: September 4, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

-Purpose: To develop and evaluate an intervention designed to improve consistent contraceptive use and dual method use in particular, among female sex workers (FSWs) in Rift Valley Province in Kenya.

Design: A qualitative descriptive study will be conducted to develop the intervention. A quasi-experimental, non-randomized, two-group, pre-/post-intervention design will be used to evaluate the intervention.

Study Population: FSWs living in Naivasha, Gilgil, and Nanyuki, Rift Valley Province.

Study Duration: Phase I - 3 months Phase II - 12 months Objectives: Develop an intervention designed to increase contraceptive use among FSWs by incorporating formative data and behavioral theory and by involving the target audience and service providers in the development of the intervention.

Examine the effectiveness of the intervention at increasing non-barrier modern contraceptive use and dual method use among FSWs.

Assess the feasibility and acceptability of the intervention, on the parts of both the clients (FSW) and service providers.

Estimate the unit cost to provide these services to one client. Study Site: Rift Valley Province, Kenya


Condition Intervention
Contraception
Behavioral: Lifestyle Counseling
Other: Standard Health Services

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Development and Evaluation of an Intervention to Increase Family Planning Use Among Female Sex Workers in Kenya

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Dual Method Contraceptive Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Dual method use is the use of a non-condom modern method in the past month plus reported use of a condom (male or female) at last sex with both paying and non-paying partner (if applicable).


Secondary Outcome Measures:
  • Acceptability and Feasibility among providers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Provider acceptability is a measure of the proportion of providers at baseline and post-intervention who are strongly in favor of providing FP services to FSWs in other DICs in Kenya and the proportion of providers who are satisfied with the training and support they received to provide FP services.

    Feasibility is a measure of the proportion of providers at baseline and post-intervention who agree or strongly agree that the FP needs of FSWs receiving services at the DIC are met. In addition, there will be a measure of the proportion of providers who report that they did not have to turn a FSW client away because they were too busy or they did not have the supplies they needed.


  • Acceptability and feasibility of intervention among Clients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Client acceptability will be measured by the proportion of clients post-intervention reporting that they are satisfied or very satisfied with the services they received at the DIC and from Peer Educators, as well as a comparison of reported service convenience and satisfaction with DIC services.

    Feasibility will be measured among clients who reported receiving FP methods or services from the DIC and we will compare reported service convenience and satisfaction with DIC services at baseline and post-intervention


  • Acceptability and feasibility of Intervention among Peer Educators (PE) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Acceptability is a measure of the the proportion of PEs who are satisfied with the training and support they received to provide FP education and counseling to FSWs in the intervention site at 6 months post-intervention and the proportion of PEs reporting satisfaction with their work and motivation to perform their responsibilities as a PE.

    Feasibility is the proportion of PEs reporting that they found their responsibilities as a PE easily manageable and would choose to be a PE again.



Estimated Enrollment: 705
Study Start Date: June 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard Health Services
Service currently being provided to FSW in Naivasha include peer education and health services delivered through a drop-in center (DIC) staff by a counselor and a nurse. For peer education, there are six modules that the peer educators walk all peers through with sessions being held once a week.
Other: Standard Health Services
Peer education and health services
Experimental: LifeStyle Counseling
A package of enhancements to the current package of services delivered to FSW will be implemented and evaluated.
Behavioral: Lifestyle Counseling

Peer educators will be trained using existing materials to deliver accurate messaging on FP/dual method use, during individual encounters and in group sessions.

Screening for unmet FP need in DICs Providing job aids to FP counselors Expanding FP methods with intra-uterine contraceptive devices (IUCD) and implants Time change in DIC hours of operation


Detailed Description:

The goal of this study is to develop and evaluate a theory-based intervention that could be incorporated into routine health services to improve the sexual and reproductive health of women who engage in sex work if demonstrated to be effective. To accomplish this goal, the study will be conducted in two phases. During the first phase of the study, FSWs and service providers in the study sites will assist in the design of the intervention, in an effort to increase the likelihood that it will be accepted, feasible, and effective. Brief formative research will be conducted with FSWs and service providers, followed by working group meetings with self-selected FSWs, service providers, and GSKenya representatives who will review data and work with study investigators and/or their designees to design the intervention. During the second phase of this study, the intervention will be implemented and evaluated.

The study is planned for two sites within Rift Valley Province, Kenya. The first "site" is comprised of two adjacent towns, Naivasha and Gilgil. The town of Nanyuki will serve as the second site.

Based on findings from the formative phase of this study, and on observations and feedback from providers, a package of enhancements to the current package of services delivered to FSW will be implemented and evaluated.

  • Family Planning (FP) Messaging for peer educators and informational materials material - Peer educators will be trained using existing materials to deliver accurate messaging on FP/dual method use, during individual encounters and in group sessions.
  • Screening for unmet FP need in drop-in centers - Integration of FP needs screening in the service delivery points will increase the number of FSW accessing FP. This will be done through sensitization of service providers and provision of a brief job aid that can be used to screening clients for unmet need, including unmet need for dual method use.
  • Providers FP counseling job aid - The AIDS, Population and Health Integrated Assistance (APHIA) Plus project will adapt the existing Balanced Counseling Strategy Plus: A Toolkit for Family Planning Service Providers Working in High HIV/Sexually Transmitted Infection (STI) Prevalence Settings for providers to use within the context of the DICs and in referral sites in the catchment area.
  • Commodities - increasing method mix - The methods that will be available to all women attending services at the DIC will be expanded. In addition to the current oral contraceptive pills, DMPA, male and female condoms, both the intra-uterine contraceptive devices (IUCD) and implants will be added to the mix of methods available.

Hours of DIC operation - Based on findings from the formative phase of the study, the hours of operation for DICs will be extended into the late evening hours to accommodate the schedules of FSW.

  Eligibility

Ages Eligible for Study:   16 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identifies as a FSW. For the purposes of this study, a FSW is defined as a woman who is sexually active and reports receiving money or goods in exchange for sex in the last 6 months as part of her source of income/livelihood.
  • Is between the ages of 16 and 49 years
  • Provides oral informed consent

Exclusion Criteria:

-

  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: NCT01957813

Contacts
Contact: Lisa Dulli, PhD, MHS 254-20-282-4000 ldulli@fhi360.org

Locations
Kenya
APHIA Plus HIV Prevention Drop-in Centers Recruiting
Naivasha, Rift Valley Province, Kenya
Contact: Lisa Dulli, PhD, MHS    254-20-282-4000    ldulli@fhi360.org   
Principal Investigator: Lisa Dulli, PhD, MHS         
APHIA Plus HIV Prevention Drop-in Centers Recruiting
Nanyuki, Rift Valley, Kenya
Contact: Lisa Dulli, PhD, MHS         
Principal Investigator: Lisa Dulli, PhD, MHS         
Sponsors and Collaborators
FHI 360
Gold Star Kenya (GSKenya)
Investigators
Principal Investigator: Lisa Dulli, PhD, MHS FHI 360
  More Information

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01957813     History of Changes
Other Study ID Numbers: 10285
Study First Received: September 4, 2013
Last Updated: April 16, 2014
Health Authority: Kenya: Institutional Review Board

Keywords provided by FHI 360:
APHIA AIDS, Population and Health Integrated Assistance
DIC Drop-in center
DMPA depot medroxyprogesterone acetate
DRH Division of Reproductive Health
FAIR Family AIDS Initiative Response
FHOK Family Health Options Kenya
FP Family planning
FGD Focus group discussion
FSW Female sex worker
GSKenya Gold Star Kenya
HTC HIV testing and counseling
HIV Human Immunodeficiency Virus
KNASP Kenya National AIDS Strategic Plan
MARPS Most at-risk populations
MoPHS Ministry of Public Health and Sanitation
MMS Ministry of Medical Services
NASCOP National AIDS and STI Control Program
RH Reproductive health
SRH Sexual and reproductive health
STI Sexually transmitted infection
USAID United States Agency for International Development

Additional relevant MeSH terms:
Medroxyprogesterone Acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014