NCT01957813

Brief Summary

-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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
719

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2014

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

September 4, 2013

Last Update Submit

September 19, 2017

Conditions

Keywords

APHIA AIDS, Population and Health Integrated AssistanceDIC Drop-in centerDMPA depot medroxyprogesterone acetateDRH Division of Reproductive HealthFAIR Family AIDS Initiative ResponseFHOK Family Health Options KenyaFP Family planningFGD Focus group discussionFSW Female sex workerGSKenya Gold Star KenyaHTC HIV testing and counselingHIV Human Immunodeficiency VirusKNASP Kenya National AIDS Strategic PlanMARPS Most at-risk populationsMoPHS Ministry of Public Health and SanitationMMS Ministry of Medical ServicesNASCOP National AIDS and STI Control ProgramRH Reproductive healthSRH Sexual and reproductive healthSTI Sexually transmitted infectionUSAID United States Agency for International Development

Outcome Measures

Primary Outcomes (1)

  • Dual Method Contraceptive Use

    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).

    6 months

Secondary Outcomes (3)

  • Acceptability and Feasibility among providers

    6 months

  • Acceptability and feasibility of intervention among Clients

    6 months

  • Acceptability and feasibility of Intervention among Peer Educators (PE)

    6 months

Study Arms (2)

Standard Health Services

OTHER

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

LifeStyle Counseling

EXPERIMENTAL

A package of enhancements to the current package of services delivered to FSW will be implemented and evaluated.

Behavioral: Lifestyle Counseling

Interventions

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

LifeStyle Counseling

Peer education and health services

Standard Health Services

Eligibility Criteria

Age16 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

APHIA Plus HIV Prevention Drop-in Centers

Naivasha, Rift Valley Province, Kenya

Location

APHIA Plus HIV Prevention Drop-in Centers

Nanyuki, Rift Valley, Kenya

Location

Related Publications (1)

  • Dulli L, Field S, Masaba R, Ndiritu J. Addressing broader reproductive health needs of female sex workers through integrated family planning/ HIV prevention services: A non-randomized trial of a health-services intervention designed to improve uptake of family planning services in Kenya. PLoS One. 2019 Jul 24;14(7):e0219813. doi: 10.1371/journal.pone.0219813. eCollection 2019.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa Dulli, PhD, MHS

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

October 8, 2013

Study Start

June 20, 2013

Primary Completion

May 30, 2014

Study Completion

May 30, 2014

Last Updated

September 21, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations