ViolenceSamPlusNCT02807259
Reducing Vulnerability in the Intimate Partnerships of Female Sex Workers Sex Workers
A study testing Multi-level intervention in people with Violence and Sexual Behaviour, run by Karnataka Health Promotion Trust at 1 site in India.
Trial summary
Female sex workers (FSWs) frequently experience violence from their intimate partners (non-paying lovers), which compromises their health and increases their the risk of infection with HIV or other sexually transmitted infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Sexual Behaviour, HIV
- What is being tested?
- Multi-level intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 809 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female Sex Workers who engage in commercial sex and who currently have an intimate partner or have had an intimate partner in the last 6 months, living in any of the 47 villages.
Who cannot join
- Female sex workers aged younger than 18 years, who do not have an intimate partner or have not had one in the last 6 months, or who live outside of the villages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Samvedana Plus: An Intervention With Female Sex Workers (FSWs) and Their Intimate Partners to Reduce Partner Violence and Increase Consistent Condom Use Within Intimate Relationships
Female sex workers (FSWs) frequently experience violence from their intimate partners (non-paying lovers), which compromises their health and increases their the risk of infection with HIV or other sexually transmitted infections. Samdevena Plus is a complex multi-level intervention that works with FSWs, their intimate partners, the sex worker community and the general population. The intervention aims to reduce partner violence and increase consistent condom use within these relationships.
The intervention consists of: (i) couples counselling sessions between FSWs and their intimate partners; (ii) separate group work among FSWs and intimate partners to increase self-esteem and encourage reflection about violence; (iii) strengthening supportive crisis management systems that address domestic and sex worker violence; (iv) training male 'champions' to encourage action against violence; and (v) training media to promote informed discussions about violence and HIV risk.The program involves changing perceptions on acceptability of physical violence as a form of discipline, challenging assumptions that give men authority over women, and working with men and women to encourage new relationship models based on equality and respect. The intervention will reach 800 FSWs and their intimate partners living in 47 villages in north Karnataka, India. The evaluation uses a cluster-randomized control trial design that introduces the intervention into half of villages for the first 24 months and the remaining half receive the intervention thereafter. The primary outcomes of the trial are: the proportion of FSWs who report: i) consistent condom use in their intimate relationship; and ii) experiencing partner violence within the past 6 months.
Read the detailed description
Female sex workers (FSWs) are at increased risk of HIV and sexually transmitted infections (STI) compared to women in the general population, and frequently experience violence in their working and domestic lives from a variety of perpetrators, which can enhance this risk. While progress has been made in addressing violence by police and clients, little work has been done to understand and prevent violence by intimate partners (IPs) among FSW populations.
Samvedana Plus is a multi-level intervention programme that works with FSWs, their IPs, the sex worker community, and the general population, and aims to reduce violence and increase consistent condom use within these 'intimate' relationships. The programme involves shifting norms around the acceptability of beating as a form of discipline, challenging gender roles that give men authority over women, and working with men and women to encourage new relationship models based on gender equity and respect. The programme will aim to cover 800 FSWs and their IPs living in 47 villages in Bagalkot district, northern Karnataka. The study is designed to assess three primary outcomes: the proportion of FSWs who report: (i) any physical or sexual partner violence; (ii) severe/moderate physical or sexual partner violence in the last 6 months; and iii) consistent condom use in their intimate relationship. The evaluation will employ a cluster-randomised controlled trial design, with 50% of the village clusters (n=24) randomly selected to receive the intervention for the first 24 months and the remaining 50% (n=23) receiving the intervention thereafter. Statisticians will be blinded to treatment arm allocation. The evaluation will use an adjusted, individual-level intention to treat analysis, comparing outcomes in intervention and control villages at endline (24 months) using a mixed effects logistic model. We will adjust for confounders in two ways: i) outcome variables are adjusted for at a cluster level using the mean baseline summaries; ii) other variables will be adjusted for an at an individual level using endline data. We will include all women survey at endline. We will also report cluster-level summaries by trial arm for each primary and secondary outcome to double check our analyses. The evaluation design will involve quantitative and qualitative assessments with (i) all FSWs who report an IP (ii) IPs; and process/ implementation monitoring.
This is an innovative intervention programme that aims to address violence by IPs as part of HIV prevention programming with FSWs. Reducing violence is expected to reduce vulnerability to HIV acquisition, and help women to work and live without fear of violence.
- Conditions
- Violence, Sexual Behaviour, HIV
- Being tested
- Multi-level intervention
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level interventionBehavioural
At the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours.
| Study group | Role | What they receive |
|---|---|---|
| Multi-level intervention | Experimental | This is a cluster-randomised controlled trial design. The unit of randomisation is village. Receives: Behavioral: Multi-level intervention |
| Control | Other | The intervention will rolled out to all participating villages after 24 months. Receives: Behavioral: Multi-level intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intimate Partner Violence
Proportion of FSWs who report experiencing any intimate partner violence in the last 6 months
Measured: 27 months after implementing the intervention
Severe Intimate Partner Violence
Proportion of sex workers experienced severe physical and/or sexual violence from intimate partners in the past 6 months
Measured: 27 months after implementing the intervention
Condom Use
Proportion of sex workers who report consistent condom use in their intimate relationship in the last 30 days
Measured: 27 months after implementing the intervention
Secondary outcomes (4)
Changes in Acceptance of Violence
Change in the proportion of FSWs who report violent actions from intimate partners to be unacceptable
Measured: 27 months after implementing the intervention
Change in Disclosure of Violence From Intimate Partners
Change in proportion of FSWs who are willing to disclose incidences of violence by their intimate partner
Measured: 27 months after implementing the intervention
Changes in Self-efficacy
Proportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP
Measured: 27 months after implementing the intervention
Changes in Solidarity Among FSWs Around Violence
Change in proportion of FSWs who support their peers to reduce incidences of violence among FSWs
Measured: 27 months after implementing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ViolenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 809 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karnataka Health Promotion Trust
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Lori Heise, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807259
- Sponsor's protocol ID
- SamPlus01
- Acronym
- SamPlus
- Status last verified
- Mar 2020
- First submitted
- 10 Jun 2016
- Last updated
- 7 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.
Publications
Javalkar P, Platt L, Prakash R, Beattie TS, Collumbien M, Gafos M, Ramanaik S, Davey C, Jewkes R, Watts C, Bhattacharjee P, Thalinja R, Dl K, Isac S, Heise L. Effectiveness of a multilevel intervention to reduce violence and increase condom use in intimate partnerships among female sex workers: cluster randomised controlled trial in Karnataka, India. BMJ Glob Health. 2019 Nov 6;4(6):e001546. doi: 10.1136/bmjgh-2019-001546. eCollection 2019.
PubMed 31798984Javalkar P, Platt L, Prakash R, Beattie T, Bhattacharjee P, Thalinja R, L KD, Sangha CATM, Ramanaik S, Collumbien M, Davey C, Moses S, Jewkes R, Isac S, Heise L. What determines violence among female sex workers in an intimate partner relationship? Findings from North Karnataka, south India. BMC Public Health. 2019 Mar 29;19(1):350. doi: 10.1186/s12889-019-6673-9.
PubMed 30922283Beattie TS, Isac S, Bhattacharjee P, Javalkar P, Davey C, Raghavendra T, Nair S, Ramanaik S, Kavitha DL, Blanchard JF, Watts C, Collumbien M, Moses S, Heise L. Reducing violence and increasing condom use in the intimate partnerships of female sex workers: study protocol for Samvedana Plus, a cluster randomised controlled trial in Karnataka state, south India. BMC Public Health. 2016 Jul 29;16:660. doi: 10.1186/s12889-016-3356-7.
PubMed 27473180
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Samvedana Plus: An Intervention With Female Sex Workers (FSWs) and Their Intimate Partners to Reduce Partner Violence and Increase Consistent Condom Use Within Intimate Relationships
- ClinicalTrials.gov ID
- NCT02807259
- Acronym / sponsor ID
- SamPlus / SamPlus01
- Conditions
- Violence, Sexual Behaviour, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 809 participants (actual)
- Lead sponsor
- Karnataka Health Promotion TrustUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Manitoba
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 26 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Female sex workers (FSWs) frequently experience violence from their intimate partners (non-paying lovers), which compromises their health and increases their the risk of infection with HIV or other sexually transmitted infections. Samdevena Plus is a complex multi-level intervention that works with FSWs, their intimate partners, the sex worker community and the general population. The intervention aims to reduce partner violence and increase consistent condom use within these relationships.
The intervention consists of: (i) couples counselling sessions between FSWs and their intimate partners; (ii) separate group work among FSWs and intimate partners to increase self-esteem and encourage reflection about violence; (iii) strengthening supportive crisis management systems that address domestic and sex worker violence; (iv) training male 'champions' to encourage action against violence; and (v) training media to promote informed discussions about violence and HIV risk.The program involves changing perceptions on acceptability of physical violence as a form of discipline, challenging assumptions that give men authority over women, and working with men and women to encourage new relationship models based on equality and respect. The intervention will reach 800 FSWs and their intimate partners living in 47 villages in north Karnataka, India. The evaluation uses a cluster-randomized control trial design that introduces the intervention into half of villages for the first 24 months and the remaining half receive the intervention thereafter. The primary outcomes of the trial are: the proportion of FSWs who report: i) consistent condom use in their intimate relationship; and ii) experiencing partner violence within the past 6 months.
Detailed description
Female sex workers (FSWs) are at increased risk of HIV and sexually transmitted infections (STI) compared to women in the general population, and frequently experience violence in their working and domestic lives from a variety of perpetrators, which can enhance this risk. While progress has been made in addressing violence by police and clients, little work has been done to understand and prevent violence by intimate partners (IPs) among FSW populations.
Samvedana Plus is a multi-level intervention programme that works with FSWs, their IPs, the sex worker community, and the general population, and aims to reduce violence and increase consistent condom use within these 'intimate' relationships. The programme involves shifting norms around the acceptability of beating as a form of discipline, challenging gender roles that give men authority over women, and working with men and women to encourage new relationship models based on gender equity and respect. The programme will aim to cover 800 FSWs and their IPs living in 47 villages in Bagalkot district, northern Karnataka. The study is designed to assess three primary outcomes: the proportion of FSWs who report: (i) any physical or sexual partner violence; (ii) severe/moderate physical or sexual partner violence in the last 6 months; and iii) consistent condom use in their intimate relationship. The evaluation will employ a cluster-randomised controlled trial design, with 50% of the village clusters (n=24) randomly selected to receive the intervention for the first 24 months and the remaining 50% (n=23) receiving the intervention thereafter. Statisticians will be blinded to treatment arm allocation. The evaluation will use an adjusted, individual-level intention to treat analysis, comparing outcomes in intervention and control villages at endline (24 months) using a mixed effects logistic model. We will adjust for confounders in two ways: i) outcome variables are adjusted for at a cluster level using the mean baseline summaries; ii) other variables will be adjusted for an at an individual level using endline data. We will include all women survey at endline. We will also report cluster-level summaries by trial arm for each primary and secondary outcome to double check our analyses. The evaluation design will involve quantitative and qualitative assessments with (i) all FSWs who report an IP (ii) IPs; and process/ implementation monitoring.
This is an innovative intervention programme that aims to address violence by IPs as part of HIV prevention programming with FSWs. Reducing violence is expected to reduce vulnerability to HIV acquisition, and help women to work and live without fear of violence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-level intervention | Experimental | Behavioral: Multi-level interventionThis is a cluster-randomised controlled trial design. The unit of randomisation is village. |
| Control | Other | Behavioral: Multi-level interventionThe intervention will rolled out to all participating villages after 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female Sex Workers who engage in commercial sex and who currently have an intimate partner or have had an intimate partner in the last 6 months, living in any of the 47 villages.
Key exclusion criteria (1 listed)
- Female sex workers aged younger than 18 years, who do not have an intimate partner or have not had one in the last 6 months, or who live outside of the villages.
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 |
|---|---|---|
| Multi-level interventionAt the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours. | Behavioural | Control, Multi-level intervention |
Primary outcome
Intimate Partner Violence
Time frame: 27 months after implementing the intervention
Proportion of FSWs who report experiencing any intimate partner violence in the last 6 months
Severe Intimate Partner Violence
Time frame: 27 months after implementing the intervention
Proportion of sex workers experienced severe physical and/or sexual violence from intimate partners in the past 6 months
Condom Use
Time frame: 27 months after implementing the intervention
Proportion of sex workers who report consistent condom use in their intimate relationship in the last 30 days
4 secondary outcomes
Changes in Acceptance of Violence
Time frame: 27 months after implementing the intervention
Change in Disclosure of Violence From Intimate Partners
Time frame: 27 months after implementing the intervention
Changes in Self-efficacy
Time frame: 27 months after implementing the intervention
Changes in Solidarity Among FSWs Around Violence
Time frame: 27 months after implementing the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31798984Javalkar P, Platt L, Prakash R, Beattie TS, Collumbien M, Gafos M, Ramanaik S, Davey C, Jewkes R, Watts C, Bhattacharjee P, Thalinja R, Dl K, Isac S, Heise L. Effectiveness of a multilevel intervention to reduce violence and increase condom use in intimate partnerships among female sex workers: cluster randomised controlled trial in Karnataka, India. BMJ Glob Health. 2019 Nov 6;4(6):e001546. doi: 10.1136/bmjgh-2019-001546. eCollection 2019.
- Derived from this study: PubMed 30922283Javalkar P, Platt L, Prakash R, Beattie T, Bhattacharjee P, Thalinja R, L KD, Sangha CATM, Ramanaik S, Collumbien M, Davey C, Moses S, Jewkes R, Isac S, Heise L. What determines violence among female sex workers in an intimate partner relationship? Findings from North Karnataka, south India. BMC Public Health. 2019 Mar 29;19(1):350. doi: 10.1186/s12889-019-6673-9.
- Derived from this study: PubMed 27473180Beattie TS, Isac S, Bhattacharjee P, Javalkar P, Davey C, Raghavendra T, Nair S, Ramanaik S, Kavitha DL, Blanchard JF, Watts C, Collumbien M, Moses S, Heise L. Reducing violence and increasing condom use in the intimate partnerships of female sex workers: study protocol for Samvedana Plus, a cluster randomised controlled trial in Karnataka state, south India. BMC Public Health. 2016 Jul 29;16:660. doi: 10.1186/s12889-016-3356-7.
- Individual participant dataSharing planned: Yes. Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.
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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.
Lori Heise principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level intervention in people with Violence and Sexual Behaviour, run by Karnataka Health Promotion Trust at 1 site in India.
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 1 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intimate Partner Violence (time frame: 27 months after implementing the intervention). The study lists 3 primary outcomes in all. 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 NCT02807259, which also lists 3 linked publications.
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 7 Apr 2020.