Trial Outcomes & Findings for Reducing Vulnerability in the Intimate Partnerships of Female Sex Workers Sex Workers (NCT NCT02807259)
NCT ID: NCT02807259
Last Updated: 2020-04-07
Results Overview
Proportion of FSWs who report experiencing any intimate partner violence in the last 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
809 participants
Primary outcome timeframe
27 months after implementing the intervention
Results posted on
2020-04-07
Participant Flow
Unit of analysis: villages
Participant milestones
| Measure |
Samvedana Plus Multi-level Intervention
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Baseline (3 Months)
STARTED
|
405 24
|
404 23
|
|
Baseline (3 Months)
COMPLETED
|
328 24
|
292 23
|
|
Baseline (3 Months)
NOT COMPLETED
|
77 0
|
112 0
|
|
Midline (3 Months)
STARTED
|
352 24
|
223 23
|
|
Midline (3 Months)
COMPLETED
|
322 24
|
189 23
|
|
Midline (3 Months)
NOT COMPLETED
|
30 0
|
34 0
|
|
Endline (3 Months)
STARTED
|
323 24
|
346 23
|
|
Endline (3 Months)
COMPLETED
|
288 24
|
259 23
|
|
Endline (3 Months)
NOT COMPLETED
|
35 0
|
87 0
|
Reasons for withdrawal
| Measure |
Samvedana Plus Multi-level Intervention
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Baseline (3 Months)
migration, refusal, not available
|
77
|
112
|
|
Midline (3 Months)
migration, refusal, not available
|
30
|
34
|
|
Endline (3 Months)
migration, refusal, not available
|
35
|
87
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Samvedana Plus Multi-level Intervention
n=328 Participants
Multi-level intervention working with sex workers, their intimate partners and communities to reduce intimate partner violence (IPV) and increase condom use
|
Wait-list Control
n=292 Participants
Wait list control.
|
Total
n=620 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 7.0 • n=328 Participants
|
35.2 years
STANDARD_DEVIATION 7.6 • n=292 Participants
|
34.5 years
STANDARD_DEVIATION 7.3 • n=620 Participants
|
|
Sex/Gender, Customized
Female
|
328 Participants
n=328 Participants
|
292 Participants
n=292 Participants
|
620 Participants
n=620 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
328 Participants
n=328 Participants
|
292 Participants
n=292 Participants
|
620 Participants
n=620 Participants
|
|
Cluster level mean of any IPV (physical or sexual violence) in past 6 months
|
31.4 Mean percentage of participants
STANDARD_DEVIATION 22.4 • n=328 Participants
|
45.0 Mean percentage of participants
STANDARD_DEVIATION 24.6 • n=292 Participants
|
38.0 Mean percentage of participants
STANDARD_DEVIATION 24.2 • n=620 Participants
|
|
Cluster level mean of severe IPV (physical and/or sexual violence) in the past 6 months
|
23.7 Mean percentage of participants
STANDARD_DEVIATION 21.1 • n=328 Participants
|
33.8 Mean percentage of participants
STANDARD_DEVIATION 23.9 • n=292 Participants
|
28.6 Mean percentage of participants
STANDARD_DEVIATION 22.8 • n=620 Participants
|
|
Cluster level mean of consistent condom use within the past 30 days
|
38.9 Mean percentage of participants
STANDARD_DEVIATION 31.7 • n=328 Participants
|
46.0 Mean percentage of participants
STANDARD_DEVIATION 23.2 • n=292 Participants
|
42.4 Mean percentage of participants
STANDARD_DEVIATION 27.8 • n=620 Participants
|
|
Cluster level mean of acceptance IPV from their intimate partners
|
59.2 Mean percentage of participants
STANDARD_DEVIATION 22.8 • n=328 Participants
|
55.1 Mean percentage of participants
STANDARD_DEVIATION 21.5 • n=292 Participants
|
57.2 Mean percentage of participants
STANDARD_DEVIATION 22.1 • n=620 Participants
|
|
Cluster level mean of disclosure of IPV
|
46.3 Mean percentage of participants
STANDARD_DEVIATION 32.5 • n=328 Participants
|
52.1 Mean percentage of participants
STANDARD_DEVIATION 28.9 • n=292 Participants
|
49.1 Mean percentage of participants
STANDARD_DEVIATION 30.6 • n=620 Participants
|
|
Cluster level mean of knowledge of self-protection strategies against IPV
|
6.2 Mean percentage of participants
STANDARD_DEVIATION 7.6 • n=328 Participants
|
7.0 Mean percentage of participants
STANDARD_DEVIATION 9.0 • n=292 Participants
|
6.6 Mean percentage of participants
STANDARD_DEVIATION 8.2 • n=620 Participants
|
|
Cluster level mean of self-efficacy to negotiate condom use with intimate partner
|
19.9 Mean percentage of participants
STANDARD_DEVIATION 17.9 • n=328 Participants
|
20.0 Mean percentage of participants
STANDARD_DEVIATION 21.3 • n=292 Participants
|
20.0 Mean percentage of participants
STANDARD_DEVIATION 19.4 • n=620 Participants
|
|
Cluster level mean of solidarity around issues of IPV
|
15.0 Mean percentage of participants
STANDARD_DEVIATION 20.0 • n=328 Participants
|
22.0 Mean percentage of participants
STANDARD_DEVIATION 20.3 • n=292 Participants
|
18.4 Mean percentage of participants
STANDARD_DEVIATION 20.2 • n=620 Participants
|
|
Cluster level mean of village population size
|
4121 Number of residents
STANDARD_DEVIATION 2694.3 • n=328 Participants
|
3755 Number of residents
STANDARD_DEVIATION 2350.1 • n=292 Participants
|
3942 Number of residents
STANDARD_DEVIATION 2511.0 • n=620 Participants
|
|
Cluster level mean of sex work population size
|
17.2 Number of sex workers
STANDARD_DEVIATION 13.7 • n=328 Participants
|
16.9 Number of sex workers
STANDARD_DEVIATION 14.8 • n=292 Participants
|
17.0 Number of sex workers
STANDARD_DEVIATION 14.1 • n=620 Participants
|
PRIMARY outcome
Timeframe: 27 months after implementing the interventionProportion of FSWs who report experiencing any intimate partner violence in the last 6 months
Outcome measures
| Measure |
Samvedana Plus Multi-level Intervention
n=288 Participants
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
n=259 Participants
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Intimate Partner Violence
|
26 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: 27 months after implementing the interventionProportion of sex workers experienced severe physical and/or sexual violence from intimate partners in the past 6 months
Outcome measures
| Measure |
Samvedana Plus Multi-level Intervention
n=288 Participants
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
n=259 Participants
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Severe Intimate Partner Violence
|
25 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 27 months after implementing the interventionProportion of sex workers who report consistent condom use in their intimate relationship in the last 30 days
Outcome measures
| Measure |
Samvedana Plus Multi-level Intervention
n=288 Participants
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
n=259 Participants
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Condom Use
|
165 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: 27 months after implementing the interventionChange in the proportion of FSWs who report violent actions from intimate partners to be unacceptable
Outcome measures
| Measure |
Samvedana Plus Multi-level Intervention
n=288 Participants
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
n=259 Participants
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Changes in Acceptance of Violence
|
193 Participants
|
188 Participants
|
SECONDARY outcome
Timeframe: 27 months after implementing the interventionChange in proportion of FSWs who are willing to disclose incidences of violence by their intimate partner
Outcome measures
| Measure |
Samvedana Plus Multi-level Intervention
n=288 Participants
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
n=259 Participants
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Change in Disclosure of Violence From Intimate Partners
|
21 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 27 months after implementing the interventionProportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP
Outcome measures
| Measure |
Samvedana Plus Multi-level Intervention
n=288 Participants
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
n=259 Participants
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Changes in Self-efficacy
|
170 Participants
|
163 Participants
|
SECONDARY outcome
Timeframe: 27 months after implementing the interventionChange in proportion of FSWs who support their peers to reduce incidences of violence among FSWs
Outcome measures
| Measure |
Samvedana Plus Multi-level Intervention
n=288 Participants
In brief, the programme, informed by prior participatory research, worked with individuals, couples, and at a community level to change the acceptability of IPV as a form of discipline, to challenge assumptions that give men authority over women, and to encourage new relationship models based on equality and respect. The intervention, implemented between April 2015 and September 2017, lasted 27 months (Box 1). It was led by a local community-based organisation (CBO) sex worker collective Chaitanya AIDS Tadegattuva Mahila Sangha (CATMS) in collaboration with the Karnataka Health Promotion Trust (KHPT). The CBO was responsible for identifying sex workers and IPs to take part in the intervention; with support from KHPT they trained outreach workers to facilitate 12 reflection sessions and provide counselling, training male champions; and building alliances with other networks to address violence against sex workers.
|
Wait List Control
n=259 Participants
Villages in the control arm continued to receive standard HIV programming (including condom distribution and HIV prevention information via peer educators) and at month 24 began to receive the intervention.
|
|---|---|---|
|
Changes in Solidarity Among FSWs Around Violence
|
112 Participants
|
81 Participants
|
Adverse Events
Multi-level Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place