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Study Overview

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
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-567a9c515d83e
Initial Registration Date:
12/23/2015
Last Update Date:
12/22/2015
Study Status:
Ongoing
Location(s):
India
Abstract:
Female sex workers (FSWs) frequently experience violence from their intimate partners (non-paying lovers), which compromises their health and increases their vulnerability to STIs/HIV. Samdevena Plus is a multi-level intervention that works with FSWs, their IPs, the sex worker community and the general population, and aims to reduce partner violence and increase consistent condom use within these relationships. The program 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 intervention will cover 800 FSWs and their IPs living in 47 villages in north Karnataka, India. The evaluation will employ a cluster-randomized control trial design with 50% of villages receiving the intervention for the first 24 months and the remaining 50% receiving the intervention thereafter. The primary outcomes of the trial will be: the proportion of FSWs who report i) consistent condom use in their intimate relationship, and ii) experiencing partner violence within the past 6 months.
Categories:
Health, Nutrition, and Population
Other
Additional Keywords:
female sex work, violence, hiv, intimate partners, vulnerability, HIV, condom use
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Lori Heise
Affiliation:
London School of Hygiene and Tropical Medicine
Name of Second PI:
Shajy Isac
Affiliation:
Karnataka Health Promotion Trust

Research Partner

Name of Partner Institution:
Karnataka Health Promotion Trust
Type of Organization:
NGO (local) or other civil society organization
Location:
India
Intervention

Intervention Overview

Intervention:
A Theory of Change model was developed which guided the choice of intervention components. At the individual level, the intervention program will work with FSWs and their IPs, both separately, as well as together in couples’ counselling sessions. The intervention will focus on: (i) the formation of structured reflection groups for FSWs, designed to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy among FSWs; (ii) the hosting of separate sessions for IPs 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 FSW Community Based Organization level, the intervention will focus on strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence. At the community level, the intervention will build an environment that encourages action against IPV by training male champions and developing folk media troops to create dialogue around gender, masculinity, violence and HIV risk.
Theory of Change:
Multiple Treatment Arms Evaluated?
No

Intervention Timing

Intervention or Program Started at time of Registration?
Yes
Start Date:
01/01/2015
End Date:
01/01/2017
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
The study will employ a Cluster-Randomized Trial with wait-list control, using the village as the unit of randomization. 50% of the village clusters (n=24) (‘Group 1’) will receive the intervention for the first 24 months. The remaining 50% of the village clusters (n=23) (‘Group 2’) will receive the intervention thereafter. All FSWs with a current or recent (past 6 months) IP will be enrolled into the study. The proposed impact evaluation has three main components: 1) Quantitative Assessment consisting of baseline, midline and endline surveys among FSWs and their intimate partners 2) Qualitative Assessment consisting of longitudinal case studies with FSWs and their intimate partners and in-depth interviews with facilitators of the program. 3) Implementation Monitoring wherein we measure the exposure of each target group to various components of the intervention, using operational records and logs.
Outcomes (Endpoints):
Primary outcomes: 1.Proportion of FSWs who report consistent condom use in their intimate relationship at endline; 2.Proportion of FSWs who report experiencing intimate partner violence in the past six months at endline. Secondary outcomes will assess the impact of the intervention on the pathways hypothesized in the Theory of Change model as potentially affecting IPV and condom use levels, including the proportion of FSWs who report: 1. Increased self-efficacy to negotiate condom use and HIV/STI testing by their IP; 2. Reduced acceptance of violence by their IPs; 3. Increased disclosure of IPV; 4. Increased solidarity among FSWs around issues of IPV; 5. Increased knowledge of self-protection strategies and sources of support for IPV. The study will aim to assess the proportion of intimate partners who report (i) perpetrating violence; and (ii) consistent condom use in the past 6 months with their FSW, as well as the secondary outcomes detailed above for FSWs. We have not included data from IPs in the main trial outcomes as it is uncertain how many IPs will agree to participate, and thus it is not possible to power the study based on anticipated IP uptake or response rates.
Unit of Analysis:
Individual
Hypotheses:
Unit of Intervention or Assignment:
Villages
Number of Clusters in Sample:
47
Number of Individuals in Sample:
800 female sex workers and their intimate partners
Size of Treatment, Control, or Comparison Subsamples:
24 intervention villages and 23 control villages

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
Cross sectional quantitative surveys will be conducted in both cohorts of villages by means of face-to-face interviews using an interviewer-administered questionnaire among FSWs and their IPs at baseline, mid-line (12 months) and following the intervention (24 months).
Data Already Collected?
No
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: