CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 809 enrolled
Drug / intervention
Multi-level interventionbehavioral
Likely dose
Not stated in record
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Search/NCT02807259
NCT02807259N/ACompleted

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

Karnataka Health Promotion Trust·interventional·Posted Jun 21, 2016·Updated Apr 7, 2020

In Brief

A clinical study evaluating Multi-level intervention for Violence and 2 related conditions. Completed, enrolled 809 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 21, 2016
Enrollment StartJan 1, 2015
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.0 years ago

Interventions

Multi-level interventionbehavioral

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.