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Reducing Vulnerability in the Intimate Partnerships of Female Sex Workers Sex Workers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02807259
Acronym
SamPlus
Enrollment
809
Registered
2016-06-21
Start date
2015-01-31
Completion date
2017-10-31
Last updated
2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Sexual Behaviour, Violence

Brief 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. 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.

Interventions

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.

Sponsors

London School of Hygiene and Tropical Medicine
CollaboratorOTHER
University of Manitoba
CollaboratorOTHER
Karnataka Health Promotion Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Intimate Partner Violence27 months after implementing the interventionProportion of FSWs who report experiencing any intimate partner violence in the last 6 months
Severe Intimate Partner Violence27 months after implementing the interventionProportion of sex workers experienced severe physical and/or sexual violence from intimate partners in the past 6 months
Condom Use27 months after implementing the interventionProportion of sex workers who report consistent condom use in their intimate relationship in the last 30 days

Secondary

MeasureTime frameDescription
Changes in Acceptance of Violence27 months after implementing the interventionChange in the proportion of FSWs who report violent actions from intimate partners to be unacceptable
Changes in Solidarity Among FSWs Around Violence27 months after implementing the interventionChange in proportion of FSWs who support their peers to reduce incidences of violence among FSWs
Change in Disclosure of Violence From Intimate Partners27 months after implementing the interventionChange in proportion of FSWs who are willing to disclose incidences of violence by their intimate partner
Changes in Self-efficacy27 months after implementing the interventionProportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP

Countries

India

Participant flow

Participants by arm

ArmCount
Samvedana Plus Multi-level Intervention
Multi-level intervention working with sex workers, their intimate partners and communities to reduce intimate partner violence (IPV) and increase condom use
328
Wait-list Control
Wait list control.
292
Total620

Withdrawals & dropouts

PeriodReasonFG000FG001
Baseline (3 Months)migration, refusal, not available77112
Endline (3 Months)migration, refusal, not available3587
Midline (3 Months)migration, refusal, not available3034

Baseline characteristics

CharacteristicSamvedana Plus Multi-level InterventionWait-list ControlTotal
Age, Continuous33.9 years
STANDARD_DEVIATION 7
35.2 years
STANDARD_DEVIATION 7.6
34.5 years
STANDARD_DEVIATION 7.3
Cluster level mean of acceptance IPV from their intimate partners59.2 Mean percentage of participants
STANDARD_DEVIATION 22.8
55.1 Mean percentage of participants
STANDARD_DEVIATION 21.5
57.2 Mean percentage of participants
STANDARD_DEVIATION 22.1
Cluster level mean of any IPV (physical or sexual violence) in past 6 months31.4 Mean percentage of participants
STANDARD_DEVIATION 22.4
45.0 Mean percentage of participants
STANDARD_DEVIATION 24.6
38.0 Mean percentage of participants
STANDARD_DEVIATION 24.2
Cluster level mean of consistent condom use within the past 30 days38.9 Mean percentage of participants
STANDARD_DEVIATION 31.7
46.0 Mean percentage of participants
STANDARD_DEVIATION 23.2
42.4 Mean percentage of participants
STANDARD_DEVIATION 27.8
Cluster level mean of disclosure of IPV46.3 Mean percentage of participants
STANDARD_DEVIATION 32.5
52.1 Mean percentage of participants
STANDARD_DEVIATION 28.9
49.1 Mean percentage of participants
STANDARD_DEVIATION 30.6
Cluster level mean of knowledge of self-protection strategies against IPV6.2 Mean percentage of participants
STANDARD_DEVIATION 7.6
7.0 Mean percentage of participants
STANDARD_DEVIATION 9
6.6 Mean percentage of participants
STANDARD_DEVIATION 8.2
Cluster level mean of self-efficacy to negotiate condom use with intimate partner19.9 Mean percentage of participants
STANDARD_DEVIATION 17.9
20.0 Mean percentage of participants
STANDARD_DEVIATION 21.3
20.0 Mean percentage of participants
STANDARD_DEVIATION 19.4
Cluster level mean of severe IPV (physical and/or sexual violence) in the past 6 months23.7 Mean percentage of participants
STANDARD_DEVIATION 21.1
33.8 Mean percentage of participants
STANDARD_DEVIATION 23.9
28.6 Mean percentage of participants
STANDARD_DEVIATION 22.8
Cluster level mean of sex work population size17.2 Number of sex workers
STANDARD_DEVIATION 13.7
16.9 Number of sex workers
STANDARD_DEVIATION 14.8
17.0 Number of sex workers
STANDARD_DEVIATION 14.1
Cluster level mean of solidarity around issues of IPV15.0 Mean percentage of participants
STANDARD_DEVIATION 20
22.0 Mean percentage of participants
STANDARD_DEVIATION 20.3
18.4 Mean percentage of participants
STANDARD_DEVIATION 20.2
Cluster level mean of village population size4121 Number of residents
STANDARD_DEVIATION 2694.3
3755 Number of residents
STANDARD_DEVIATION 2350.1
3942 Number of residents
STANDARD_DEVIATION 2511
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
India
328 Participants292 Participants620 Participants
Sex/Gender, Customized
Female
328 Participants292 Participants620 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3280 / 292
other
Total, other adverse events
0 / 3280 / 292
serious
Total, serious adverse events
0 / 3280 / 292

Outcome results

Primary

Condom Use

Proportion of sex workers who report consistent condom use in their intimate relationship in the last 30 days

Time frame: 27 months after implementing the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Samvedana Plus Multi-level InterventionCondom Use165 Participants
Wait List ControlCondom Use162 Participants
p-value: 0.74895% CI: [0.58, 1.47]Mixed Models Analysis
Primary

Intimate Partner Violence

Proportion of FSWs who report experiencing any intimate partner violence in the last 6 months

Time frame: 27 months after implementing the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Samvedana Plus Multi-level InterventionIntimate Partner Violence26 Participants
Wait List ControlIntimate Partner Violence21 Participants
Comparison: Power calculations were conducted assuming an IPV prevalence (past 12 months) of 47% and consistent condom use (past 12 months) of 38% based on initial assessments. The power calculation was performed by analysing simulated data from 800 women, distributed across clusters using empirical data with a range in variance across cluster-level proportions of IPV (15% to 25% of the total variation) and a narrow range of effect sizes (risk ratio= 0.75-0.80).p-value: 0.29895% CI: [0.71, 3.01]Mixed Models Analysis
Primary

Severe Intimate Partner Violence

Proportion of sex workers experienced severe physical and/or sexual violence from intimate partners in the past 6 months

Time frame: 27 months after implementing the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Samvedana Plus Multi-level InterventionSevere Intimate Partner Violence25 Participants
Wait List ControlSevere Intimate Partner Violence18 Participants
p-value: 0.37895% CI: [0.68, 2.81]Mixed Models Analysis
Secondary

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

Time frame: 27 months after implementing the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Samvedana Plus Multi-level InterventionChange in Disclosure of Violence From Intimate Partners21 Participants
Wait List ControlChange in Disclosure of Violence From Intimate Partners15 Participants
p-value: 0.37295% CI: [0.42, 10.26]Mixed Models Analysis
Secondary

Changes in Acceptance of Violence

Change in the proportion of FSWs who report violent actions from intimate partners to be unacceptable

Time frame: 27 months after implementing the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Samvedana Plus Multi-level InterventionChanges in Acceptance of Violence193 Participants
Wait List ControlChanges in Acceptance of Violence188 Participants
p-value: 0.02595% CI: [0.4, 0.94]Mixed Models Analysis
Secondary

Changes in Self-efficacy

Proportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP

Time frame: 27 months after implementing the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Samvedana Plus Multi-level InterventionChanges in Self-efficacy170 Participants
Wait List ControlChanges in Self-efficacy163 Participants
p-value: 0.84595% CI: [0.61, 1.5]Mixed Models Analysis
Secondary

Changes in Solidarity Among FSWs Around Violence

Change in proportion of FSWs who support their peers to reduce incidences of violence among FSWs

Time frame: 27 months after implementing the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Samvedana Plus Multi-level InterventionChanges in Solidarity Among FSWs Around Violence112 Participants
Wait List ControlChanges in Solidarity Among FSWs Around Violence81 Participants
p-value: 0.04295% CI: [1.02, 2.82]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026