Sexual ViolenceNCT04147455
Preventing Sexual Violence in College Men: RealConsent for Use in Vietnam
A study testing Adapted RealConsent in people with Sexual Violence, run by Emory University at 2 sites in Vietnam.
Trial summary
This study is a randomized controlled trial using a web-based adaptation of the RealConsent program among eligible college men in Hanoi, Vietnam. This study will test the impact of the program on promoting prosocial bystander behavior and preventing sexual violence perpetration, through improvements in the seven… Read more about this study
- Who is it for?
- Ages 18 to 24 years, men only
- Conditions the study is for
- Sexual Violence
- What is being tested?
- Adapted RealConsent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 793 participants
- Where
- 2 sitesVietnam
- Study dates
- 11 Sep 2019to 2 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Identifying as heterosexual or bisexual
- Enrolled as a freshman at Hanoi Medical University or Thang Long University on 9/1/2019
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Thang Long University
Hanoi, 100000
Hanoi Medical University
Hanoi, 116001
About this study
Official title: Preventing Sexual Violence in College Men: Adaptation and Impact Evaluation of RealConsent for Use in Vietnam
This study is a randomized controlled trial using a web-based adaptation of the RealConsent program among eligible college men in Hanoi, Vietnam. This study will test the impact of the program on promoting prosocial bystander behavior and preventing sexual violence perpetration, through improvements in the seven knowledge, attitudinal, and emotional mediators over a seven month study period, with a baseline survey and two follow-up surveys.
Read the detailed description
Sexual violence is any sexual act committed against a person without freely given consent. Men and women may experience sexual violence, but most victims are women. Women's first experiences of sexual violence often occur in adolescence. In Asia and the Pacific, about 14% of sexually experienced adolescent girls report forced sexual debut. Thus, early prevention with men is critical; yet, young men often are difficult to reach and may resist programs that target sexual violence, not seeing themselves as potential perpetrators. Prevention with men that integrates a bystander framework, which treats men as "allies" of women, is one way to target attitudes and behaviors while decreasing resistance to participation. In this study, the researchers will adapt an existing program for use with men attending one of two universities in Hanoi, Vietnam. This study will test the impact of the adapted program on knowledge/attitudinal/emotional mediators, and in turn, on sexual violence perpetration and prosocial bystander behavior in this target group. The adapted program is a novel, six-session, web-based serial drama and educational program designed to prevent sexual violence perpetration and to enhance prosocial bystander behavior in young men. The program has reduced the incidence of sexual violence among men attending an urban, public university in the Southeastern United States.
After conducting interviews with men and women, and focus group discussions with college men and university stakeholders the researchers will produce a web-based adaptation of the RealConsent program in Vietnam. The researchers will then conduct a randomized controlled trial to test the impact of the adapted program, relative to a health-education control condition, on knowledge/attitudinal/emotional mediators, and in turn, on sexually violent behaviors, and prosocial bystander behavior in freshmen men attending two universities in Hanoi. This project will be the first to adapt and to test the impact of a novel, theoretically grounded, web-based intervention to prevent sexual violence perpetration and to promote prosocial bystander behavior among young men for use in a middle-income country. If this study shows that the adapted program is effective cross-culturally, it will have exceptional potential for scale-up to prevent men's perpetration of sexual violence against women globally.
- Conditions
- Sexual Violence
- Being tested
- Adapted RealConsent, Health Education Control Condition
- Keywords
- Behavioral intervention, Violent behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted RealConsentBehavioural
The program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants will view six 30-minute modules designed to prevent sexual violence in young men
Health Education Control ConditionBehavioural
Participants will view six 30-minute web-based serial drama modules designed to promote health.
| Study group | Role | What they receive |
|---|---|---|
| RealConsent | Experimental | Participants randomized to this study arm will receive an adapted program of RealConsent. Receives: Behavioral: Adapted RealConsent |
| Health Education Control Condition | Active comparator | Participants in the control arm will receive a web-based health promotion program. Receives: Behavioral: Health Education Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Contact Sexual Violence Via Physical Tactics
Acts of contact sexual violence using physical tactics (force or threat of harm) were assessed using 7 items from the Sexual Experiences Survey. The 7 items are scored on a scale from 0 (zero acts) to 3 (multiple acts), indicating how many times the participant reported engaging in a specific tactic in order to engage in contact sexual violence, including unwanted touching, rape, and attempted rape. The numbers of participants indicating they used physical tactics at least once (scores of 1 or 2) to perpetrate any of seven acts of contact physical violence (in the past twelve months, for the baseline assessment, or since last completing the questionnaire) are presented here.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Number of Participants Reporting Contact Sexual Violence Via Non-physical Tactics
Acts of contact sexual violence using non-physical tactics (verbal coercion, lying, or intoxication) were assessed using 7 items from the Sexual Experiences Survey. The 7 items are scored on a scale from 0 (zero tactics) to 3 (multiple tactics), indicating how many times the participant reported engaging in a specific tactic in order to engage in contact sexual violence, including unwanted touching, rape, and attempted rape. The numbers of participants indicating they used non-physical tactics at least once (scores of 1 or 2) to perpetrate any of seven acts of contact physical violence (in the past twelve months, for the baseline assessment, or since last completing the questionnaire) are presented here.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Number of Participants Reporting Non-contact Sexual Violence
Acts of non-contact sexual violence were assessed using 10 items from the Sexual Experiences Survey. The 10 items are scored on a scale from 0 (zero acts) to 3 (multiple acts), indicating how many times the participant reported engaging in an act. The numbers of participants indicating they engaged in at least one act of non-contact sexually violent behavior (scores of 1 or 2) in the past twelve months, for the baseline assessment, or since last completing the questionnaire are presented here.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Number of Participants Reporting Prosocial Bystander Behavior
Participants were asked if they had engaged in any of four prosocial bystander behaviors in the past 12 months (or since the last time completing the questionnaire). Items are scored as 0 = never performed, 1 = performed once, 2 = performed more than once. The numbers of participants who report engaging in at least one of four prosocial bystander behaviors at least once are presented here.
Measured: Six months following baseline
Secondary outcomes (8)
Knowledge of Legal Definitions of Assault and Rape Scale Score
Knowledge of the law is assessed with 22 items where respondents indicate if they think the situations described are illegal (scored as 1), legal, but harmful (2), or not sexual violence (3), with example items including "Forcing a person to have oral sex" and "Pressuring someone to have sex." Items were re-coded such that responses indicating an accurate estimate or overestimate of the illegality and harms of sexual violence were coded as "1" and items indicating an underestimation as of the illegality and harms of sexual violence were coded as "0". Total scores range from 0 to 22 with higher scores indicating greater awareness of laws and consequences related to sexual violence.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Knowledge of Informed Consent to Have Sex Score
Knowledge of sexual consent is assessed with 15 items where respondents indicate how much they agree with each statement on a 5-point Likert scale of 1 to 5, where 1 = totally agree and 5 = totally disagree. This scale was adapted from fifteen items of the Sexual Consent Attitudes and Behaviors scale. Example items include "The need to ask for sexual consent DECREASES as the length of a dating relationship INCREASES" and "If your partner initiates sexual contact, it is okay to continue, even if she/he is drunk". Several items were reverse-coded to maintain common valence, and all response options were re-coded to range from 0-4. Total scores range from 0 to 60 where higher scores indicate greater knowledge about sexual consent.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Gender Roles Score
The Gender Role Attitudes (GRA) scale measures men's gender role attitudes. The fifteen-item scale was adapted from the Gender Equitable Men (GEM) scale, a scale that was adapted for use in Nepal from the GEM scale, the Male Role Norms Inventory (MRNI)-Adolescent-revised scale, the Gender Attitudes Scale, and the International Men and Gender Equality Survey (IMAGES). Example items included: "A woman should obey her husband even when she disagrees with him" and "Men should be the ones to initiate dating relationships". Response options were coded using a 5-point Likert scale ranging from totally agree (1) to totally disagree (5). Two items needed to be reverse coded to maintain common valence, and all items were re-coded to range from 0-4, resulting in a theoretical score range of 0-60, with higher scores indicating more equitable attitudes.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Myths and Realities About Sexual Violence Score
Beliefs about what other men think about myths and realities of sexual violence was to be assessed with 24 items asking respondents to indicate how much they agree with each statement. Responses were to be given on a scale from 1 to 5 where 1 = totally agree and 5 = totally disagree. Total scores range from 24 to 120 with lower scores indicating that the respondent thinks men his age agree more with myths concerning sexual violence.
Measured: Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
Sexual Coercion Score
This 19-item scale was adapted from the Sexual Coercion in Intimate Relationships scale. Examples of items in the scale included: "Saying that a person would have sex with you if they truly love you" and "Asking your dating partner repeatedly to perform a sexual act after they have said that they do not want to". Response options were coded into "No" (0), "Yes" (1) and "Unsure" (2). Three items had to be reverse coded to maintain common valence. For analysis, "No" and "Unsure" were re-coded into one response option. Scores range from 0-19. Higher scores indicate a greater understanding of behaviors that are sexually coercive.
Measured: Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
Sexual Violence Myths Score
Rape attitudes were assessed with 28 items presenting myths about rape. Items are scored on a 5-point Likert scale from 1 to 5 where 1 = totally agree and 5 = totally disagree. The Rape Myth Attitudes (RMA) scale measures the extent of men's endorsement (or non-endorsement) of common rape myths. This scale was adapted from fourteen items of the Illinois Rape Myth Scale-Short Form and eleven items of the College Date Rape Attitude and Behavior Survey. Example items included: "When guys rape, it is usually because of their strong desire for sex" and "In most cases when a woman was raped, she was asking for it". Several items were reverse-coded to maintain common valence, and all response options were re-coded 0-4, resulting in a theoretical range of 0-112, with higher scores indicating less endorsement of rape myths.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Alcohol and Consent Score
Beliefs about consent in terms of alcohol use are assessed with 5 items adapted from the College Date Rape Attitudes and Behaviors scale where respondents indicate how much they agree with each statement. Responses are on a scale from 1 = totally agree to 5 = totally disagree. Items were re-coded to be grounded at zero. Total scores range from 0 to 20 where higher scores indicate more understanding of sexual consent under the influence of alcohol.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Rape Empathy Score
Empathy for rape victims was assessed with a modified version of the Rape Empathy Scale (RES). This assessment includes 17 items where participants were asked to choose between two statements, one of which reflected greater empathy towards rapists ("I understand the helplessness a rapist might feel during a rape, since he cannot control his actions") and one of which reflected greater empathy towards victims ("I understand the helplessness a victim might feel during a rape"). Responses are scored as 1 (more empathy for victim) or 0 (more empathy for perpetrator) and total scores range from 0 to 17 where higher scores indicate more empathy towards rape victims.
Measured: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start11 Sep 2019
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Creative Initiatives in Health and Population
- Responsible party
- Principal investigator, Kathryn Yount, Emory University
- Investigators
- Kathryn Yount, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147455
- Sponsor's protocol ID
- IRB00099860
- Status last verified
- Sep 2021
- First submitted
- 30 Oct 2019
- Last updated
- 8 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data will be available for sharing, including data dictionaries, with the exception of potentially sensitive items on sexual violence perpetration.
Publications
Yount KM, Minh TH, Trang QT, Cheong YF, Bergenfeld I, Sales JM. Preventing sexual violence in college men: a randomized-controlled trial of GlobalConsent. BMC Public Health. 2020 Sep 1;20(1):1331. doi: 10.1186/s12889-020-09454-2.
PubMed 32873262Yount KM, Cheong YF, Bergenfeld I, Trang QT, Sales JM, Li Y, Minh TH. Impacts of GlobalConsent, a Web-Based Social Norms Edutainment Program, on Sexually Violent Behavior and Bystander Behavior Among University Men in Vietnam: Randomized Controlled Trial. JMIR Public Health Surveill. 2023 Jan 27;9:e35116. doi: 10.2196/35116.
PubMed 36705965
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Sexual Violence in College Men: Adaptation and Impact Evaluation of RealConsent for Use in Vietnam
- ClinicalTrials.gov ID
- NCT04147455
- Acronym / sponsor ID
- IRB00099860
- Conditions
- Sexual Violence
- Keywords
- Behavioral intervention, Violent behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Center for Creative Initiatives in Health and Population
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial using a web-based adaptation of the RealConsent program among eligible college men in Hanoi, Vietnam. This study will test the impact of the program on promoting prosocial bystander behavior and preventing sexual violence perpetration, through improvements in the seven knowledge, attitudinal, and emotional mediators over a seven month study period, with a baseline survey and two follow-up surveys.
Detailed description
Sexual violence is any sexual act committed against a person without freely given consent. Men and women may experience sexual violence, but most victims are women. Women's first experiences of sexual violence often occur in adolescence. In Asia and the Pacific, about 14% of sexually experienced adolescent girls report forced sexual debut. Thus, early prevention with men is critical; yet, young men often are difficult to reach and may resist programs that target sexual violence, not seeing themselves as potential perpetrators. Prevention with men that integrates a bystander framework, which treats men as "allies" of women, is one way to target attitudes and behaviors while decreasing resistance to participation. In this study, the researchers will adapt an existing program for use with men attending one of two universities in Hanoi, Vietnam. This study will test the impact of the adapted program on knowledge/attitudinal/emotional mediators, and in turn, on sexual violence perpetration and prosocial bystander behavior in this target group. The adapted program is a novel, six-session, web-based serial drama and educational program designed to prevent sexual violence perpetration and to enhance prosocial bystander behavior in young men. The program has reduced the incidence of sexual violence among men attending an urban, public university in the Southeastern United States.
After conducting interviews with men and women, and focus group discussions with college men and university stakeholders the researchers will produce a web-based adaptation of the RealConsent program in Vietnam. The researchers will then conduct a randomized controlled trial to test the impact of the adapted program, relative to a health-education control condition, on knowledge/attitudinal/emotional mediators, and in turn, on sexually violent behaviors, and prosocial bystander behavior in freshmen men attending two universities in Hanoi. This project will be the first to adapt and to test the impact of a novel, theoretically grounded, web-based intervention to prevent sexual violence perpetration and to promote prosocial bystander behavior among young men for use in a middle-income country. If this study shows that the adapted program is effective cross-culturally, it will have exceptional potential for scale-up to prevent men's perpetration of sexual violence against women globally.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RealConsent | Experimental | Behavioral: Adapted RealConsentParticipants randomized to this study arm will receive an adapted program of RealConsent. |
| Health Education Control Condition | Active comparator | Behavioral: Health Education Control ConditionParticipants in the control arm will receive a web-based health promotion program. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Identifying as heterosexual or bisexual
- Enrolled as a freshman at Hanoi Medical University or Thang Long University on 9/1/2019
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted RealConsentThe program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants will view six 30-minute modules designed to prevent sexual violence in young men | Behavioural | RealConsent |
| Health Education Control ConditionParticipants will view six 30-minute web-based serial drama modules designed to promote health. | Behavioural | Health Education Control Condition |
Primary outcome
Number of Participants Reporting Contact Sexual Violence Via Physical Tactics
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Acts of contact sexual violence using physical tactics (force or threat of harm) were assessed using 7 items from the Sexual Experiences Survey. The 7 items are scored on a scale from 0 (zero acts) to 3 (multiple acts), indicating how many times the participant reported engaging in a specific tactic in order to engage in contact sexual violence, including unwanted touching, rape, and attempted rape. The numbers of participants indicating they used physical tactics at least once (scores of 1 or 2) to perpetrate any of seven acts of contact physical violence (in the past twelve months, for the baseline assessment, or since last completing the questionnaire) are presented here.
Number of Participants Reporting Contact Sexual Violence Via Non-physical Tactics
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Acts of contact sexual violence using non-physical tactics (verbal coercion, lying, or intoxication) were assessed using 7 items from the Sexual Experiences Survey. The 7 items are scored on a scale from 0 (zero tactics) to 3 (multiple tactics), indicating how many times the participant reported engaging in a specific tactic in order to engage in contact sexual violence, including unwanted touching, rape, and attempted rape. The numbers of participants indicating they used non-physical tactics at least once (scores of 1 or 2) to perpetrate any of seven acts of contact physical violence (in the past twelve months, for the baseline assessment, or since last completing the questionnaire) are presented here.
Number of Participants Reporting Non-contact Sexual Violence
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Acts of non-contact sexual violence were assessed using 10 items from the Sexual Experiences Survey. The 10 items are scored on a scale from 0 (zero acts) to 3 (multiple acts), indicating how many times the participant reported engaging in an act. The numbers of participants indicating they engaged in at least one act of non-contact sexually violent behavior (scores of 1 or 2) in the past twelve months, for the baseline assessment, or since last completing the questionnaire are presented here.
Number of Participants Reporting Prosocial Bystander Behavior
Time frame: Six months following baseline
Participants were asked if they had engaged in any of four prosocial bystander behaviors in the past 12 months (or since the last time completing the questionnaire). Items are scored as 0 = never performed, 1 = performed once, 2 = performed more than once. The numbers of participants who report engaging in at least one of four prosocial bystander behaviors at least once are presented here.
8 secondary outcomes
Knowledge of Legal Definitions of Assault and Rape Scale Score
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Knowledge of Informed Consent to Have Sex Score
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Gender Roles Score
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Myths and Realities About Sexual Violence Score
Time frame: Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
Sexual Coercion Score
Time frame: Baseline, Posttest (immediately after completing the intervention), 6 Months after intervention
Sexual Violence Myths Score
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Alcohol and Consent Score
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Rape Empathy Score
Time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32873262Yount KM, Minh TH, Trang QT, Cheong YF, Bergenfeld I, Sales JM. Preventing sexual violence in college men: a randomized-controlled trial of GlobalConsent. BMC Public Health. 2020 Sep 1;20(1):1331. doi: 10.1186/s12889-020-09454-2.
- Derived from this study: PubMed 36705965Yount KM, Cheong YF, Bergenfeld I, Trang QT, Sales JM, Li Y, Minh TH. Impacts of GlobalConsent, a Web-Based Social Norms Edutainment Program, on Sexually Violent Behavior and Bystander Behavior Among University Men in Vietnam: Randomized Controlled Trial. JMIR Public Health Surveill. 2023 Jan 27;9:e35116. doi: 10.2196/35116.
- Individual participant dataSharing planned: Yes. All de-identified data will be available for sharing, including data dictionaries, with the exception of potentially sensitive items on sexual violence perpetration.
Related trials for Sexual Violence
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Enrolling by invitation
The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
Acute Stress Symptoms, Sexual Violence
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Yount, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted RealConsent in people with Sexual Violence, run by Emory University at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Contact Sexual Violence Via Physical Tactics (time frame: Baseline, immediately after completing the 3 week intervention, 6 months after completing the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04147455, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.