Ignite Creation Date:
2024-05-06 @ 10:11 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03186534
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2017-06-12
Brief Title:
Randomized Trial of an HIV Prevention and Relationship Education Program for Young Male Couples
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Efficacy of Couples-Based HIV Prevention in Vulnerable Young Men
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2GETHER
Brief Summary:
Young gay bisexual and other men who have sex with men YMSM are the only risk group in which rates of new HIV infections are on the rise There has been a relative dearth of research dedicated to understanding these health disparities between gaybisexual and heterosexual youth and even less has focused on identifying factors that might promote resilience against negative health outcomes Understanding both risk factors and processes of resilience is critical in developing efficacious interventions to improve health in this population
Through a grant from the National Institutes of Health the investigators completed formative research with young male couples Qualitative interviews identified preferences for couples-based intervention format and content While coupled YMSM expressed some interest in HIV prevention participants were most interested in building relationship skills Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood Further the influence of older partners partner violence and drinking before sex were strongest in emerging adulthood Informed by these the research team developed 2GETHER which aims to reduce HIV transmission risk in couples by enhancing relationship functioning 2GETHER is a four session program The first two sessions are group sessions aimed at skills building and the second two sessions are individualized couple sessions aimed at skills implementation Modules address communication skills coping with stress both general and sexual minority-specific stress relationship sexual satisfaction and HIV transmission risk within the dyad and with outside partners 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status couples learn to use behavioral and biomedical approaches to prevent both HIV acquisition eg HIV testing condom use pre-exposure prophylaxis and transmission eg medication adherence to reduce viral load with an overarching emphasis on the health of the couple
The investigators completed a pilot trial of 2GETHER with funding from Northwestern University The pilot trial enrolled 57 couples N114 and demonstrated feasibility acceptability and preliminary efficacy of 2GETHER This pilot trial used a non-randomized pre-post-test design because the goal was to evaluate feasibility acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT Post-test occurred 2 weeks post-intervention or 2 months post-baseline The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview At the 2-week post-test the investigators observed significant decreases in HIV risk behavior improvements in motivation to reduce HIV risk and improvements in relationship investment
The current study will conduct a randomized controlled trial RCT to test the efficacy of 2GETHER a novel couples-based intervention for young men who have sex with men YMSM that aims to reduce HIV transmission risk by optimizing relationship functioning The investigators will conduct an RCT with 200 dyads total individual N400 who will be randomized to receive the 2GETHER intervention or an attention-matched couples-based positive affect promotion program
Through a grant from the National Institutes of Health the investigators completed formative research with young male couples Qualitative interviews identified preferences for couples-based intervention format and content While coupled YMSM expressed some interest in HIV prevention participants were most interested in building relationship skills Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood Further the influence of older partners partner violence and drinking before sex were strongest in emerging adulthood Informed by these the research team developed 2GETHER which aims to reduce HIV transmission risk in couples by enhancing relationship functioning 2GETHER is a four session program The first two sessions are group sessions aimed at skills building and the second two sessions are individualized couple sessions aimed at skills implementation Modules address communication skills coping with stress both general and sexual minority-specific stress relationship sexual satisfaction and HIV transmission risk within the dyad and with outside partners 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status couples learn to use behavioral and biomedical approaches to prevent both HIV acquisition eg HIV testing condom use pre-exposure prophylaxis and transmission eg medication adherence to reduce viral load with an overarching emphasis on the health of the couple
The investigators completed a pilot trial of 2GETHER with funding from Northwestern University The pilot trial enrolled 57 couples N114 and demonstrated feasibility acceptability and preliminary efficacy of 2GETHER This pilot trial used a non-randomized pre-post-test design because the goal was to evaluate feasibility acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT Post-test occurred 2 weeks post-intervention or 2 months post-baseline The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview At the 2-week post-test the investigators observed significant decreases in HIV risk behavior improvements in motivation to reduce HIV risk and improvements in relationship investment
The current study will conduct a randomized controlled trial RCT to test the efficacy of 2GETHER a novel couples-based intervention for young men who have sex with men YMSM that aims to reduce HIV transmission risk by optimizing relationship functioning The investigators will conduct an RCT with 200 dyads total individual N400 who will be randomized to receive the 2GETHER intervention or an attention-matched couples-based positive affect promotion program
Detailed Description:
The investigators will conduct a randomized controlled trial RCT with 200 dyads total individual N400 who will be randomized to receive the 2GETHER HIV prevention and relationship education intervention or an attention-matched couples-based positive affect enhancement program Each program both 2GETHER and control delivers 4 sessions over 1-month 2 group sessions of 4-8 couples focused on relationship skills building and 2 individual couple sessions focused on skill utilization Couples complete skills practice homework between sessions and receive community-based resources
Eligibility Screening Participants will be screened either online over the phone with a member of the study staff or in-person at Howard Brown Health Center depending on the mode of recruitment recruitment activities described below a Online screening - young men who have sex with men YMSM who are recruited via social media ads or via email contact ie email listservs HBHC Primary Care patients will be linked directly to the online eligibility screener and YMSM recruited from flyer postings will be given a URL and the option to screen online Potential participants will be greeted with a brief description of the project and will be asked if they are willing to answer some questions to assess their eligibility Those who agree to participate will answer questions about their age gender and relationship status Participants who meet initial eligibility criteria will be shown a message telling them that they are preliminarily eligible for the study These participants will be asked to provide contact information for themselves and for their partner If they do not consent to give contact information for their partner the participant will be responsible for ensuring the partner also completes the screener If they provide contact information for their partner study staff will contact the partner and provide him with a link to complete the screener b Phone screening - YMSM who opt to call the study phone number on the flyer will be screened by a study staff member They will be given an overview of the study the ability to ask questions and will then be asked if they are interested in participating and asking their partner to participate If they agree the staff member will administer the online screener over the phone All other procedures are analogous to the online screening c In-person screening at Howard Brown Health Center - Upon completion of their HIV testing and counseling session or their primary care visit at Howard Brown YMSM will be provided with a brief description of the 2GETHER project asked if they are interested in participating in the study If interested participants will complete the online eligibility screener All other eligibility screener procedures are analogous to those described above for online screening Screening data will be retained during the course of the study in order to help identify duplicate participants or participants faking eligibility
Couple Confirmation In order to participate in this study both partners in the couple must complete the screener meet all eligibility criteria and be confirmed by study staff to be an actual couple Couple confirmation will involve separate calls to each partner with a series of questions to elicit information about the individual his partner and their relationship ie information only an actual couple would know about one another After these phone calls study staff will review the responses to determine agreement Once staff has confirmed that the two participants are a couple they will be contacted to schedule an in-person meeting where they will complete a consent form and the baseline assessment
Baseline Assessment After couple confirmation the couple will be scheduled for an in-person appointment After consenting to participate in the study in-person consent process described below the 2 partners will be directed to complete a baseline assessment This approximately 60-minute questionnaire will assess demographics relationship characteristics HIV knowledge and motivations HIV risk and prevention behaviors and other relevant psychosocial outcomes eg substance use mental health The couple will then be given additional information about the structure of the intervention and scheduling options The baseline assessment will occur 1 week prior to the first session of the 2GETHER intervention Urethralrectal STI testing will also occur at baseline
Randomization Dyads will be randomized to the 2GETHER intervention or attention-matched control using stratified block randomization which involves performing simple randomization many times within blocks eg ABBA AABB etc ensuring equal N in each condition while avoiding temporal imbalance The eligibility screener will assess age and known HIV status Blocks will be stratified to ensure equal numbers of couples assigned to each condition in which a at least 1 member is HIV and b 1 member is aged 30 Randomization will occur at completion of baseline survey Baseline interviews will occur 1 week prior to 2GETHERcontrol session 1 and dyads will only be baselined if they are available for all sessions Scheduling conflicts arise 2 group cohorts are run simultaneously so dyads that miss a group session can be scheduled for the same session in the other cohort
2GETHER Intervention The study intervention will take place over the course of 4 weeks 4 sessions total approximately 1 session per week beginning with 2 group sessions and ending with 2 individual couple sessions During group sessions 4-8 couples will work with 2 facilitators in the couples sessions each individual couple will work with a single facilitator Intervention content will be delivered via a combination of facilitated discussion group andor couple activities worksheets videos and didactic material Skills will be reinforced using interactive homework assignments between sessions which will be reviewed at the beginning of the subsequent session After each session participants will complete a brief online evaluation to assess acceptability of the intervention content
Session 1 The first group session 4 hours will consist of four modules 1 an orientation to the intervention 2 characteristics of healthy relationships 3 effective communication skills and 4 reducing HIV risk in relationships In the orientation module couples will learn about the structure and purpose of the intervention collaboratively develop a list of group rules with the facilitators eg confidentiality respect for others and will complete ice-breaker activities to facilitate participants comfort with the other group members In the healthy relationships module couples will learn how to identify healthy and unhealthy relationship patterns discuss past experiences with healthyunhealthy relationships and then develop a list of pleasurable activities in which couples can engage in the Chicago area eg free museum nights Couples will identify one activity they will do in the next week In the effective communication skills module couples will learn about several effective and ineffective communication patterns watch brief videos demonstrating these patterns and briefly practice effective communication skills with their partners Couples will be asked to practice using effective communication skills and identify instances in which they use ineffective communication with their partners before the next session Finally in the reducing HIV risk module couples will learn about HIV risks in same-sex male relationships sexual behaviors that pose different levels of HIV risk different methods of HIV prevention including condom use pre-exposure prophylaxis PrEP and post-exposure prophylaxis PEP and where one can be tested for HIV and obtain condoms and PrEPPEP
Session 2 The second group session 2 hours will cover 1 coping skills 2 problem-solving3 social and community support and 4 acceptance In the coping skills modules couples will learn the various types of strategies that can be used to cope with stress and will discuss which strategies are the most effective in various situations In the problem-solving module couples will learn a simple framework for addressing problems and stress in their relationship In the social and community support module couples will participants identify the social networks and communities that can serve as additional support for each individual and the couple Finally the acceptance module will teach couples who to identify stresses that cant be changed and will review strategies for accepting stressful situations without changing them in order to reduce their impact on the health of the couple
Session 3 The first couples session 1 hour will consist of more in-depth discussion and practice of communication skills Facilitators will elicit reasons why utilizing effective communication and minimizing ineffective communication are important for each couple as well as ways in which using effective or ineffective communication has affected their relationship in the past Couples will identify two areas of conflict or disagreement that can be targeted in a 30-minute skills practice Each partner will take at least 1-2 turns communicating their concerns about the disagreement listening to their partner communicate their concerns and responding to their partners concerns respectfully The facilitator will provide each partner with feedback Before the next session couples will be asked to continue practicing effective communication on 1-2 additional topics identified in this session to continue identifying and rectifying ineffective communication and engage in another positive activity as a couple
Session 4 The second couples session 15 hours will be focused on relationship sexual agreements Couples will engage in a facilitated discussion about their perceived risk of HIV and identify their motivations for reducing HIV risk in their current relationship andor with outside partners Couples will learn about relationship agreements ie agreements about whether or not it is permissible to have sex with partners outside of the relationships and generate list of pros and cons about having outside partners and having relationship agreements in general Couples who do not have a relationship agreement will with the help of the facilitator begin drafting an agreement that meets each partners emotional sexual and health needs Couples who have an existing agreement will identify whether their current relationship agreement meets these needs and determine whether and how to amend their relationship agreement Couples will also learn about how relationship agreements may change over time how to renegotiate agreements how to communicate about a broken agreement and how different agreement types impact HIV risk Finally the facilitator will review strategies for maintaining healthy relationships in the long-term including discussing strategies the couples can use to handle lapses in their newly acquired healthy relationship skills
Positive Affect Promotion Program Control Condition
The control condition will be a positive affect program developed by Co-I Dr Moskowitz that matches attention and the mixed group and individual format of 2GETHER Developed based on Stress and Coping Theory and the Broaden-and-Build theory of positive emotion this program aims to reduce distress and improve wellbeing by increasing attention to positive emotions and reducing impact of negative emotions In this trial Sessions 1 and 2 will be group sessions facilitated by two individuals and focused on didactic instruction of strategies for increasing positive affect in both individuals and couples Analogous to 2GETHER Sessions 3 and 4 will be individual couple sessions facilitated by one individual that focus on skills implementation in the dyad Justification The positive affect program has received high acceptability ratings and has been found to improve psychological distress in HIV MSM but analyses find no effect on transmission risk behavior and we would not anticipate it would do so among HIV- MSM This control condition is both ethical and appropriate for this RCT it delivers beneficial skills but it does not address the primary mechanisms of change in 2GETHER ie communication sexual health negotiation skills Exit interviews from our pilot trial indicate that this positive affect intervention would be beneficial to coupled YMSM but would not address 2GETHERs mechanisms of change I like the thought of learning to be more mindful and I think that would be easier to do in a group setting so we would enjoy the program But I also feel that the new topics are less focused on communicating effectively as a couple so I do not feel it would have had the same effect for me personally Facilitators Facilitators will hold a bachelors degree at minimum and have direct experience working with young adults andor MSM Facilitators will receive project- and university-specific training and will be certified in HIV testing and counseling Weekly supervision groups will review and discuss issues that arise during sessions Using BA-level facilitators means 2GETHER will be easier to implement in the community
Post-Session Evaluations After each of the 4 intervention sessions or single sessions in control condition participants will complete brief online evaluations that assess feasibility and acceptability of the intervention as well as provide ratings of the facilitators These surveys will be programmed in REDCap software and links to the evaluations will be emailed to participants after completing each session of the intervention
Assessment Timepoints Baseline assessment will occur in-person Each individual will complete informed consent separately to ensure both are willingable to participate Intermediate follow-up assessments will be completed remotely online to minimize burden at 3- 6- and 9-months 12-month follow-up will be completed in-person to facilitate collection of biological endpoints STI testing All assessments will last approximately 45-60 minutes will assess the same or analogous constructs
Fidelity The study will use 2 strategies to ensure fidelity to the intervention manual First an independent assessor will sit in on 20 of group sessions Second the study will audio-record all individual couples sessions and an independent assessor will review 20 of sessions for fidelity Independent assessors will complete a checklist indicating whether or not each component of each intervention session was completed by facilitators
Eligibility Screening Participants will be screened either online over the phone with a member of the study staff or in-person at Howard Brown Health Center depending on the mode of recruitment recruitment activities described below a Online screening - young men who have sex with men YMSM who are recruited via social media ads or via email contact ie email listservs HBHC Primary Care patients will be linked directly to the online eligibility screener and YMSM recruited from flyer postings will be given a URL and the option to screen online Potential participants will be greeted with a brief description of the project and will be asked if they are willing to answer some questions to assess their eligibility Those who agree to participate will answer questions about their age gender and relationship status Participants who meet initial eligibility criteria will be shown a message telling them that they are preliminarily eligible for the study These participants will be asked to provide contact information for themselves and for their partner If they do not consent to give contact information for their partner the participant will be responsible for ensuring the partner also completes the screener If they provide contact information for their partner study staff will contact the partner and provide him with a link to complete the screener b Phone screening - YMSM who opt to call the study phone number on the flyer will be screened by a study staff member They will be given an overview of the study the ability to ask questions and will then be asked if they are interested in participating and asking their partner to participate If they agree the staff member will administer the online screener over the phone All other procedures are analogous to the online screening c In-person screening at Howard Brown Health Center - Upon completion of their HIV testing and counseling session or their primary care visit at Howard Brown YMSM will be provided with a brief description of the 2GETHER project asked if they are interested in participating in the study If interested participants will complete the online eligibility screener All other eligibility screener procedures are analogous to those described above for online screening Screening data will be retained during the course of the study in order to help identify duplicate participants or participants faking eligibility
Couple Confirmation In order to participate in this study both partners in the couple must complete the screener meet all eligibility criteria and be confirmed by study staff to be an actual couple Couple confirmation will involve separate calls to each partner with a series of questions to elicit information about the individual his partner and their relationship ie information only an actual couple would know about one another After these phone calls study staff will review the responses to determine agreement Once staff has confirmed that the two participants are a couple they will be contacted to schedule an in-person meeting where they will complete a consent form and the baseline assessment
Baseline Assessment After couple confirmation the couple will be scheduled for an in-person appointment After consenting to participate in the study in-person consent process described below the 2 partners will be directed to complete a baseline assessment This approximately 60-minute questionnaire will assess demographics relationship characteristics HIV knowledge and motivations HIV risk and prevention behaviors and other relevant psychosocial outcomes eg substance use mental health The couple will then be given additional information about the structure of the intervention and scheduling options The baseline assessment will occur 1 week prior to the first session of the 2GETHER intervention Urethralrectal STI testing will also occur at baseline
Randomization Dyads will be randomized to the 2GETHER intervention or attention-matched control using stratified block randomization which involves performing simple randomization many times within blocks eg ABBA AABB etc ensuring equal N in each condition while avoiding temporal imbalance The eligibility screener will assess age and known HIV status Blocks will be stratified to ensure equal numbers of couples assigned to each condition in which a at least 1 member is HIV and b 1 member is aged 30 Randomization will occur at completion of baseline survey Baseline interviews will occur 1 week prior to 2GETHERcontrol session 1 and dyads will only be baselined if they are available for all sessions Scheduling conflicts arise 2 group cohorts are run simultaneously so dyads that miss a group session can be scheduled for the same session in the other cohort
2GETHER Intervention The study intervention will take place over the course of 4 weeks 4 sessions total approximately 1 session per week beginning with 2 group sessions and ending with 2 individual couple sessions During group sessions 4-8 couples will work with 2 facilitators in the couples sessions each individual couple will work with a single facilitator Intervention content will be delivered via a combination of facilitated discussion group andor couple activities worksheets videos and didactic material Skills will be reinforced using interactive homework assignments between sessions which will be reviewed at the beginning of the subsequent session After each session participants will complete a brief online evaluation to assess acceptability of the intervention content
Session 1 The first group session 4 hours will consist of four modules 1 an orientation to the intervention 2 characteristics of healthy relationships 3 effective communication skills and 4 reducing HIV risk in relationships In the orientation module couples will learn about the structure and purpose of the intervention collaboratively develop a list of group rules with the facilitators eg confidentiality respect for others and will complete ice-breaker activities to facilitate participants comfort with the other group members In the healthy relationships module couples will learn how to identify healthy and unhealthy relationship patterns discuss past experiences with healthyunhealthy relationships and then develop a list of pleasurable activities in which couples can engage in the Chicago area eg free museum nights Couples will identify one activity they will do in the next week In the effective communication skills module couples will learn about several effective and ineffective communication patterns watch brief videos demonstrating these patterns and briefly practice effective communication skills with their partners Couples will be asked to practice using effective communication skills and identify instances in which they use ineffective communication with their partners before the next session Finally in the reducing HIV risk module couples will learn about HIV risks in same-sex male relationships sexual behaviors that pose different levels of HIV risk different methods of HIV prevention including condom use pre-exposure prophylaxis PrEP and post-exposure prophylaxis PEP and where one can be tested for HIV and obtain condoms and PrEPPEP
Session 2 The second group session 2 hours will cover 1 coping skills 2 problem-solving3 social and community support and 4 acceptance In the coping skills modules couples will learn the various types of strategies that can be used to cope with stress and will discuss which strategies are the most effective in various situations In the problem-solving module couples will learn a simple framework for addressing problems and stress in their relationship In the social and community support module couples will participants identify the social networks and communities that can serve as additional support for each individual and the couple Finally the acceptance module will teach couples who to identify stresses that cant be changed and will review strategies for accepting stressful situations without changing them in order to reduce their impact on the health of the couple
Session 3 The first couples session 1 hour will consist of more in-depth discussion and practice of communication skills Facilitators will elicit reasons why utilizing effective communication and minimizing ineffective communication are important for each couple as well as ways in which using effective or ineffective communication has affected their relationship in the past Couples will identify two areas of conflict or disagreement that can be targeted in a 30-minute skills practice Each partner will take at least 1-2 turns communicating their concerns about the disagreement listening to their partner communicate their concerns and responding to their partners concerns respectfully The facilitator will provide each partner with feedback Before the next session couples will be asked to continue practicing effective communication on 1-2 additional topics identified in this session to continue identifying and rectifying ineffective communication and engage in another positive activity as a couple
Session 4 The second couples session 15 hours will be focused on relationship sexual agreements Couples will engage in a facilitated discussion about their perceived risk of HIV and identify their motivations for reducing HIV risk in their current relationship andor with outside partners Couples will learn about relationship agreements ie agreements about whether or not it is permissible to have sex with partners outside of the relationships and generate list of pros and cons about having outside partners and having relationship agreements in general Couples who do not have a relationship agreement will with the help of the facilitator begin drafting an agreement that meets each partners emotional sexual and health needs Couples who have an existing agreement will identify whether their current relationship agreement meets these needs and determine whether and how to amend their relationship agreement Couples will also learn about how relationship agreements may change over time how to renegotiate agreements how to communicate about a broken agreement and how different agreement types impact HIV risk Finally the facilitator will review strategies for maintaining healthy relationships in the long-term including discussing strategies the couples can use to handle lapses in their newly acquired healthy relationship skills
Positive Affect Promotion Program Control Condition
The control condition will be a positive affect program developed by Co-I Dr Moskowitz that matches attention and the mixed group and individual format of 2GETHER Developed based on Stress and Coping Theory and the Broaden-and-Build theory of positive emotion this program aims to reduce distress and improve wellbeing by increasing attention to positive emotions and reducing impact of negative emotions In this trial Sessions 1 and 2 will be group sessions facilitated by two individuals and focused on didactic instruction of strategies for increasing positive affect in both individuals and couples Analogous to 2GETHER Sessions 3 and 4 will be individual couple sessions facilitated by one individual that focus on skills implementation in the dyad Justification The positive affect program has received high acceptability ratings and has been found to improve psychological distress in HIV MSM but analyses find no effect on transmission risk behavior and we would not anticipate it would do so among HIV- MSM This control condition is both ethical and appropriate for this RCT it delivers beneficial skills but it does not address the primary mechanisms of change in 2GETHER ie communication sexual health negotiation skills Exit interviews from our pilot trial indicate that this positive affect intervention would be beneficial to coupled YMSM but would not address 2GETHERs mechanisms of change I like the thought of learning to be more mindful and I think that would be easier to do in a group setting so we would enjoy the program But I also feel that the new topics are less focused on communicating effectively as a couple so I do not feel it would have had the same effect for me personally Facilitators Facilitators will hold a bachelors degree at minimum and have direct experience working with young adults andor MSM Facilitators will receive project- and university-specific training and will be certified in HIV testing and counseling Weekly supervision groups will review and discuss issues that arise during sessions Using BA-level facilitators means 2GETHER will be easier to implement in the community
Post-Session Evaluations After each of the 4 intervention sessions or single sessions in control condition participants will complete brief online evaluations that assess feasibility and acceptability of the intervention as well as provide ratings of the facilitators These surveys will be programmed in REDCap software and links to the evaluations will be emailed to participants after completing each session of the intervention
Assessment Timepoints Baseline assessment will occur in-person Each individual will complete informed consent separately to ensure both are willingable to participate Intermediate follow-up assessments will be completed remotely online to minimize burden at 3- 6- and 9-months 12-month follow-up will be completed in-person to facilitate collection of biological endpoints STI testing All assessments will last approximately 45-60 minutes will assess the same or analogous constructs
Fidelity The study will use 2 strategies to ensure fidelity to the intervention manual First an independent assessor will sit in on 20 of group sessions Second the study will audio-record all individual couples sessions and an independent assessor will review 20 of sessions for fidelity Independent assessors will complete a checklist indicating whether or not each component of each intervention session was completed by facilitators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None