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

NCT02807259 | Completed Results

• 1 other identifier: SamPlus01
• Study Type: interventional
• Target: 809
• Locations: 1 country
• Sites: 1

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.

Conditions

Violence; Sexual Behaviour; HIV

Outcome Measures

Primary Outcomes (3)

• Intimate Partner Violence

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

  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

  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

  27 months after implementing the intervention

Secondary Outcomes (4)

• Changes in Acceptance of Violence

  27 months after implementing the intervention

• Change in Disclosure of Violence From Intimate Partners

  27 months after implementing the intervention

• Changes in Self-efficacy

  27 months after implementing the intervention

• Changes in Solidarity Among FSWs Around Violence

  27 months after implementing the intervention

Study Arms (2)

Multi-level intervention

EXPERIMENTAL

This is a cluster-randomised controlled trial design. The unit of randomisation is village.

Behavioral: Multi-level intervention

Control

OTHER

The intervention will rolled out to all participating villages after 24 months.

Behavioral: Multi-level intervention

Interventions

Multi-level intervention BEHAVIORAL

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.

Control; Multi-level intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karnataka Health Promotion Trust: lead
• London School of Hygiene and Tropical Medicine: collaborator
• University of Manitoba: collaborator

Study Sites (1)

Karnataka Health Promotion Trust

Bengaluru, Karnataka, India

Location

Related Publications (3)

• 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.

  PMID: 31798984 DERIVED

• Javalkar 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.

  PMID: 30922283 DERIVED

• Beattie 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.

  PMID: 27473180 DERIVED

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Results Point of Contact

• Title: Prakash Javalkar
• Organization: Karnataka Health Promotion Trust

prakashj@khpt.org

+91 80 4040 0200

Study Officials

• Lori Heise

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 21, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 7, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)