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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
| University of Manitoba | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-level intervention | Experimental | This is a cluster-randomised controlled trial design. The unit of randomisation is village. |
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| Control | Other | The intervention will rolled out to all participating villages after 24 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Acceptance of Violence | Change in the proportion of FSWs who report violent actions from intimate partners to be unacceptable | 27 months after implementing the intervention |
| Change in Disclosure of Violence From Intimate Partners |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Heise | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karnataka Health Promotion Trust | Bengaluru | Karnataka | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31798984 | Derived | 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. | |
| 30922283 |
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Data will be anonymised and made available for secondary analyses on request, following publication of trial findings.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Baseline (3 Months) |
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| Midline (3 Months) |
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| Endline (3 Months) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Wait-list Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intimate Partner Violence | Proportion of FSWs who report experiencing any intimate partner violence in the last 6 months | Posted | Count of Participants | Participants | 27 months after implementing the intervention |
|
Data on adverse events were monitored for the duration of the intervention implementation (27 months).
A community advisory board of sex workers was set up to inform all aspects of study design, implementation and consent procedures, to ensure it was acceptable to the community and to help monitor any adverse events (defined as a report of sexual/physical violence). Outreach workers collected reports of violence during regular sessions with sex workers, completing a report when incidents occurred. These reports were monitored and reported to the Crisis Management Committee.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multi-level Intervention | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prakash Javalkar | Karnataka Health Promotion Trust | +91 80 4040 0200 | prakashj@khpt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2017 | Dec 18, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 30, 2014 | Dec 18, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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|
Change in proportion of FSWs who are willing to disclose incidences of violence by their intimate partner
| 27 months after implementing the intervention |
| Changes in Self-efficacy | Proportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP | 27 months after implementing the intervention |
| Changes in Solidarity Among FSWs Around Violence | Change in proportion of FSWs who support their peers to reduce incidences of violence among FSWs | 27 months after implementing the intervention |
| 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. |
| 27473180 | 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. |
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| NOT COMPLETED |
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Wait list control.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Cluster level mean of any IPV (physical or sexual violence) in past 6 months | Mean | Standard Deviation | Mean percentage of participants |
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| Cluster level mean of severe IPV (physical and/or sexual violence) in the past 6 months | Mean | Standard Deviation | Mean percentage of participants |
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| Cluster level mean of consistent condom use within the past 30 days | Mean | Standard Deviation | Mean percentage of participants |
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| Cluster level mean of acceptance IPV from their intimate partners | Mean | Standard Deviation | Mean percentage of participants |
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| Cluster level mean of disclosure of IPV | Mean | Standard Deviation | Mean percentage of participants |
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| Cluster level mean of knowledge of self-protection strategies against IPV | Mean | Standard Deviation | Mean percentage of participants |
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| Cluster level mean of self-efficacy to negotiate condom use with intimate partner | Mean | Standard Deviation | Mean percentage of participants |
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| Cluster level mean of solidarity around issues of IPV | Mean | Standard Deviation | Mean percentage of participants |
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| Cluster level mean of village population size | Mean | Standard Deviation | Number of residents |
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| Cluster level mean of sex work population size | Mean | Standard Deviation | Number of sex workers |
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| OG001 | 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. |
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| Primary | Severe Intimate Partner Violence | Proportion of sex workers experienced severe physical and/or sexual violence from intimate partners in the past 6 months | Posted | Count of Participants | Participants | 27 months after implementing the intervention |
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| Primary | Condom Use | Proportion of sex workers who report consistent condom use in their intimate relationship in the last 30 days | Posted | Count of Participants | Participants | 27 months after implementing the intervention |
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| Secondary | Changes in Acceptance of Violence | Change in the proportion of FSWs who report violent actions from intimate partners to be unacceptable | Posted | Count of Participants | Participants | 27 months after implementing the intervention |
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| 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 | Posted | Count of Participants | Participants | 27 months after implementing the intervention |
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| Secondary | Changes in Self-efficacy | Proportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP | Posted | Count of Participants | Participants | 27 months after implementing the intervention |
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| Secondary | Changes in Solidarity Among FSWs Around Violence | Change in proportion of FSWs who support their peers to reduce incidences of violence among FSWs | Posted | Count of Participants | Participants | 27 months after implementing the intervention |
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| 0 |
| 328 |
| 0 |
| 328 |
| 0 |
| 328 |
| EG001 | Control | Peer educators, HIV counselling, condom distribution. The intervention will rolled out to all participating villages after 24 months. | 0 | 292 | 0 | 292 | 0 | 292 |
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