ContraceptionNCT01957813
Evaluation of a Peer Education Program to Promote Family Planning Among Female Sex Workers in Kenya
A study testing Lifestyle Counseling and Standard Health Services in people with Contraception, run by FHI 360 at 2 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Lifestyle Counseling and Standard Health Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 719 participants
- Where
- 2 sitesKenya
- Study dates
- 20 Jun 2013to 30 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
APHIA Plus HIV Prevention Drop-in Centers
Naivasha, Rift Valley Province
APHIA Plus HIV Prevention Drop-in Centers
Nanyuki, Rift Valley
About this study
Official title: Development and Evaluation of an Intervention to Increase Family Planning Use Among Female Sex Workers in Kenya
-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.
Read more
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
Read the 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.
- Conditions
- Contraception
- Being tested
- Lifestyle Counseling, Standard Health Services
- Keywords
- 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingBehavioural
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
Standard Health ServicesOther
Peer education and health services
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (3)
Acceptability and Feasibility among providers
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.
Measured: 6 months
Acceptability and feasibility of intervention among Clients
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
Measured: 6 months
Acceptability and feasibility of Intervention among Peer Educators (PE)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start20 Jun 2013
- Primary completion30 May 2014
- Study completion30 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Gold Star Kenya (GSKenya)
- Responsible party
- Sponsor
- Investigators
- Lisa Dulli, PhD, MHS, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957813
- Sponsor's protocol ID
- 10285
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2013
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31339919
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Intervention to Increase Family Planning Use Among Female Sex Workers in Kenya
- ClinicalTrials.gov ID
- NCT01957813
- Acronym / sponsor ID
- 10285
- Conditions
- Contraception
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Gold Star Kenya (GSKenya)
- Study start
- 20 Jun 2013 (actual)
- Primary completion
- 30 May 2014 (actual)
- Study completion
- 30 May 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
-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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Health Services | Other | Other: Standard Health ServicesService 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. |
| LifeStyle Counseling | Experimental | Behavioral: Lifestyle CounselingA package of enhancements to the current package of services delivered to FSW will be implemented and evaluated. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle CounselingPeer 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 | Behavioural | LifeStyle Counseling |
| Standard Health ServicesPeer education and health services | Other | Standard Health Services |
Primary outcome
Dual Method Contraceptive Use
Time frame: 6 months
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).
3 secondary outcomes
Acceptability and Feasibility among providers
Time frame: 6 months
Acceptability and feasibility of intervention among Clients
Time frame: 6 months
Acceptability and feasibility of Intervention among Peer Educators (PE)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Derived from this study: PubMed 31339919Dulli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Dulli, PhD, MHS principal investigator
FHI 360
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Counseling and Standard Health Services in people with Contraception, run by FHI 360 at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Method Contraceptive Use (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01957813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.