HIV Risk ReductionD2FNCT02111720
Disclosure to Family
A study testing Maybe, Maybe Not and Comprehensive Risk Counseling and Services in people with HIV Risk Reduction and Attention Control Case Management, run by University of South Florida at 1 site in United States.
Trial summary
The decision to disclose one's serostatus to family members creates considerable emotional strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While disclosure to family members has been linked to positive outcomes including increased social support, improved health outcomes (i.e.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Risk Reduction, Attention Control Case Management
- What is being tested?
- Maybe, Maybe Not and Comprehensive Risk Counseling and Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 17 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive men and women
- over the age of 18
- indicate an interest in learning more about disclosure
- have at least one family member who does not know of diagnosis
- sexually active in past 90 days
- speak and understand English
- plan on living in Tampa area for at least one year
Who cannot join
- not HIV-positive
- children under the age of 18
- not able to speak and understand English
- do not plan on living in Tampa area for the year
- not sexually active in last 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maybe, Maybe Not: Deciding to Disclose HIV Status to Family
The decision to disclose one's serostatus to family members creates considerable emotional strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While disclosure to family members has been linked to positive outcomes including increased social support, improved health outcomes (i.e., sexual, physical, mental), reduced loneliness and stress, and improved HIV disease management, the decision not to disclose can also lead to positive outcomes. To date, most research about serostatus disclosure has focused on the act of disclosing - the who, what, where, and when of disclosing - rather than the decision process involved. The investigator's long-range goal is to further refine and evaluate an intervention designed to enhance HIV disclosure decision-making among PLWH. To reach this goal, the investigators are proposing a course of study with the following specific aims: Specific Aim 1. Assess the effectiveness of the intervention relative to an attention-control condition on a variety of primary outcomes related to disclosure and health. Specific Aim 2: Examine the effects of the intervention over time. Specific Aim 3: Explore the potential mediating effects of disclosure decision making on the primary outcomes. Specific Aim 4: Explore potential moderating effects of participant demographics (e.g., gender, age), relationship characteristics (i.e., relationship satisfaction, proximity, importance of disclosure), and contextual variables related to family (e.g., adaptability, problem-solving) on intervention effectiveness. Specific Aim 5: Evaluate the effects of treatment engagement, retention and expectations on outcomes.
Read the detailed description
A two-armed, randomized, parallel group, attention-placebo control design is proposed to assess the relative efficacy of the intervention. Participants who meet the enrollment criteria will complete baseline assessments prior to being randomized into one of two intervention groups: the experimental group or the ACCM. The ACCM will function as a concurrent control group. All participants will receive four individualized sessions of interventional procedures, regardless of assignment. The first 3 sessions will take place at weekly intervals, with a 4-week wait period between sessions 3 and 4. The wait period permits those in the experimental arm to consider disclosure decisions, and to make disclosures if they so choose. Participants in both groups will return for assessment and a booster session at 3-months post-baseline. Participants in both groups will also return at 6- and 12-months post-baseline for follow-up assessments.
Experimental Condition is: Maybe or Maybe Not. The intervention is an individual-level 4-session + 3 month booster series designed to assist persons with HIV in making decisions regarding the disclosure of their HIV serostatus to family members. The CTD asserts that HIV-positive persons weigh the rewards and costs of disclosing their status to family. Whenever the rewards outweigh the costs, disclosure occurs. In previous work, this theory has proven to be an effective model in understanding disclosure to family and friends. The goals of session one are to introduce participants to the intervention, to assess current decision context, to assist in the clarification of participant values, and to encourage the participant to set specific goals for disclosure decision-making. Participants will explore their current family relationships, and determine which family members they want to consider telling, and which family members they know they don't want to tell. Participants are then asked to complete the disclosure decisions assessment with the facilitator. This assessment is used to gather information about the decision context specific to each family member. Participants identify each family members' disclosure status (i.e., aware/not aware), as well as other key attributes of each relationship which inform the decision such as importance of disclosure and satisfaction with the relationship. A series of handouts designed to initiate awareness of the decision process are then provided and discussed. For example, a handout entitled, "Questions to ask yourself as you think about disclosing to family members," is used to stimulate and expand awareness of the context within which disclosure decisions will be made. The goals for session two are to explore the participants' motivations to disclose or not to disclose and the potential costs and rewards of both disclosing and not disclosing. Strategies that can be employed to minimize disclosure-related costs are also reviewed. The goals for session three are to guide participants through disclosure decision making, and to support comfort/acceptance with decisions made. Only when a decision to disclose has been made, participants will complete a Family Disclosure Worksheet, to rehearse potential disclosure conversations, and to prepare for the potential reactions of family members. Where the decision is made not to disclose, emphasis is placed on supporting comfort/acceptance with this decision. Through discussions with their facilitator, participants are encouraged to consider the ongoing nature of the decision-making and evaluation processes. The goal of session four is to support the decision-making process. If applicable, the session begins with a review of the Family Disclosure Worksheet and all other intervention materials. The decision-making process is reviewed, and comfort and acceptance with each decision is again explored. Participants are encouraged to reflect on their readiness to make disclosure decisions with respect to specific family members. If the decision not to disclose is made, the session focus includes support of that decision, and a discussion of the cues for assessment and re-evaluation. Preliminary data from the pilot study suggest that disclosures were still occurring at 3-months post-intervention, indicating that a booster session may be helpful. In addition to initial exposure to "treatment," effective interventions generally include some follow-up or booster sessions to support durability of impact. Low frequency booster sessions following the termination of an intensive treatment have been proposed as one method that may assist in maintaining treatment gains, and have been shown to be effective for a variety of therapeutic interventions including behavioral family therapy, anger management, assertions skills training, behavioral psychotherapy, and HIV prevention. In this study a 3-month booster session will be used to reinforce the effects of the intervention through continued discussion of disclosure decisions in the preceding months, strategies used in disclosing, and rewards and costs of decision-making.
The Control condition is: Attention control case management (ACCM). The CDC's HIV Prevention case management program "Comprehensive Risk Counseling and Services" (CRCS) will be used to provide the attention-placebo control. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. HIV-positive individuals often have numerous psychosocial, financial, and medical challenges, and may not immediately acknowledge the need for prevention services because their basic living needs (e.g., housing) are more salient. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients. Trust is a key element in the ability to work with participants. In the ACCM, the facilitator will work in cooperation with the participant using a problem-solving approach geared to build trust, and will place emphasis on connecting the participant to community-based services and supports. As operationalized by the AIDS and Substance Abuse Program, the initial CRCS meeting provides an opportunity to describe the program, gather information and establish rapport. For those who present with immediate needs such as for shelter or medical care, this first meeting may provide an opportunity for linking the participant to services immediately. The initial treatment plan is developed in the second meeting. The facilitator will go through each of six general areas with the participant to gather a history and picture of the current situation: (1) substance abuse; (2) basic needs; (3) health care; (4) mental health; (5) legal issues; and (6) support systems. Once this review is complete, an initial intervention plan is developed with specific goals and objectives. Case management is a continual process of developing goals, working to meet those goals and addressing obstacles. Thus, the ACCM can mimic the experimental condition, and will be delivered on the same session schedule as the experimental condition and will include a comparable booster session at 3 months. Facilitators will be extensively trained by the PI and will be knowledgeable regarding local resources for HIV-positive persons. Facilitators will be qualified to make appropriate referrals to service providers and to local AIDS service organizations (ASOs), and will evaluate participant referral follow-through by encouraging a discussion of referral activities at each session. Resource lists provided to participants in both groups during the first session will include contact information for a 24-hour hotline in the event of emergency.
- Being tested
- Maybe, Maybe Not, Comprehensive Risk Counseling and Services
- Keywords
- HIV, Disclosure, Family, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maybe, Maybe NotBehavioural
The goals of session one are to introduce participants to the intervention, to assess current decision context, to assist in the clarification of participant values, and to encourage the participant to set specific goals for disclosure decision-making. The goals for session two are to explore the participants' motivations to disclose or not to disclose and the potential costs and rewards of both disclosing and not disclosing. The goals for session three are to guide participants through disclosure decision making, and to support comfort/acceptance with decisions made. The goal of session four is to support the decision-making process. The booster session is used to reinforce the effects of the intervention through continued discussion of disclosure decisions in the preceding months, strategies used in disclosing, and rewards and costs of decision-making.
Comprehensive Risk Counseling and ServicesBehavioural
Also called CRCS
CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs.CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients.
| Study group | Role | What they receive |
|---|---|---|
| Maybe, Maybe Not | Experimental | The intervention is an individual-level 4-session + 3 month booster series designed to assist persons with HIV in making decisions regarding the disclosure of their HIV serostatus to family members. Receives: Behavioral: Maybe, Maybe Not |
| Comprehensive Risk Counseling and Services | Active comparator | Comprehensive Risk Counseling and Services (CRCS) will be used to provide the attention-placebo control (CDC, 2006). CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. Receives: Behavioral: Comprehensive Risk Counseling and Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 52 weeks in HIV Transmission Risk
Ordinal measure of HIV transmission risk. The ordinal measure is constructed from information provided by the participant on the last five sexual encounters during the prior 30 days, with the highest risk assigned to encounters involving discordant anal/vaginal intercourse, unprotected, with a discordant partner (XEF)
Measured: Baseline, Week 7, Week 12, Week 24, Week 52
Secondary outcomes (3)
Change from baseline to 52 weeks in the number of family members to whom participants have disclosed their positive serostatus
At baseline, the ASSIS interview tool is used to identify participants' family members who do not know the participants' serostatus. During the study period, they will report any of these family members to whom they disclosure their serostatus (i.e., the status of disclosure has changed from "not disclosed to" to "disclosed to")
Measured: Baseline, Week 7, Week 12, Week 24, Week 52
Change from baseline to 52 weeks in the odds of disclosure to sex partners
Participants will indicate, for each of their last 5 encounters, whether or not they disclosed their serostatus to sex partners (DPA)
Measured: Baseline, Week 7, Week 12, Week 24, Week 52
Change from baseline to 52 weeks in the proportion of sex partners disclosed to
Participants will indicate the number of sex partners disclosed to during the prior 30 days (DBC)
Measured: Baseline, Week 7, Week 12, Week 24, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJul 2013
- Primary completion17 Aug 2020 (estimated)
- Study completion17 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Risk ReductionStudies of the same condition, open and under way.
- 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
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Julianne M Serovich, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111720
- Sponsor's protocol ID
- MH097486
- Other IDs
- R01MH097486
- Acronym
- D2F
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2014
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maybe, Maybe Not: Deciding to Disclose HIV Status to Family
- ClinicalTrials.gov ID
- NCT02111720
- Acronym / sponsor ID
- D2F / MH097486
- Keywords
- HIV, Disclosure, Family, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 351 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2013
- Primary completion
- 17 Aug 2020 (estimated)
- Study completion
- 17 Aug 2020 (estimated)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The decision to disclose one's serostatus to family members creates considerable emotional strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While disclosure to family members has been linked to positive outcomes including increased social support, improved health outcomes (i.e., sexual, physical, mental), reduced loneliness and stress, and improved HIV disease management, the decision not to disclose can also lead to positive outcomes. To date, most research about serostatus disclosure has focused on the act of disclosing - the who, what, where, and when of disclosing - rather than the decision process involved. The investigator's long-range goal is to further refine and evaluate an intervention designed to enhance HIV disclosure decision-making among PLWH. To reach this goal, the investigators are proposing a course of study with the following specific aims: Specific Aim 1. Assess the effectiveness of the intervention relative to an attention-control condition on a variety of primary outcomes related to disclosure and health. Specific Aim 2: Examine the effects of the intervention over time. Specific Aim 3: Explore the potential mediating effects of disclosure decision making on the primary outcomes. Specific Aim 4: Explore potential moderating effects of participant demographics (e.g., gender, age), relationship characteristics (i.e., relationship satisfaction, proximity, importance of disclosure), and contextual variables related to family (e.g., adaptability, problem-solving) on intervention effectiveness. Specific Aim 5: Evaluate the effects of treatment engagement, retention and expectations on outcomes.
Detailed description
A two-armed, randomized, parallel group, attention-placebo control design is proposed to assess the relative efficacy of the intervention. Participants who meet the enrollment criteria will complete baseline assessments prior to being randomized into one of two intervention groups: the experimental group or the ACCM. The ACCM will function as a concurrent control group. All participants will receive four individualized sessions of interventional procedures, regardless of assignment. The first 3 sessions will take place at weekly intervals, with a 4-week wait period between sessions 3 and 4. The wait period permits those in the experimental arm to consider disclosure decisions, and to make disclosures if they so choose. Participants in both groups will return for assessment and a booster session at 3-months post-baseline. Participants in both groups will also return at 6- and 12-months post-baseline for follow-up assessments.
Experimental Condition is: Maybe or Maybe Not. The intervention is an individual-level 4-session + 3 month booster series designed to assist persons with HIV in making decisions regarding the disclosure of their HIV serostatus to family members. The CTD asserts that HIV-positive persons weigh the rewards and costs of disclosing their status to family. Whenever the rewards outweigh the costs, disclosure occurs. In previous work, this theory has proven to be an effective model in understanding disclosure to family and friends. The goals of session one are to introduce participants to the intervention, to assess current decision context, to assist in the clarification of participant values, and to encourage the participant to set specific goals for disclosure decision-making. Participants will explore their current family relationships, and determine which family members they want to consider telling, and which family members they know they don't want to tell. Participants are then asked to complete the disclosure decisions assessment with the facilitator. This assessment is used to gather information about the decision context specific to each family member. Participants identify each family members' disclosure status (i.e., aware/not aware), as well as other key attributes of each relationship which inform the decision such as importance of disclosure and satisfaction with the relationship. A series of handouts designed to initiate awareness of the decision process are then provided and discussed. For example, a handout entitled, "Questions to ask yourself as you think about disclosing to family members," is used to stimulate and expand awareness of the context within which disclosure decisions will be made. The goals for session two are to explore the participants' motivations to disclose or not to disclose and the potential costs and rewards of both disclosing and not disclosing. Strategies that can be employed to minimize disclosure-related costs are also reviewed. The goals for session three are to guide participants through disclosure decision making, and to support comfort/acceptance with decisions made. Only when a decision to disclose has been made, participants will complete a Family Disclosure Worksheet, to rehearse potential disclosure conversations, and to prepare for the potential reactions of family members. Where the decision is made not to disclose, emphasis is placed on supporting comfort/acceptance with this decision. Through discussions with their facilitator, participants are encouraged to consider the ongoing nature of the decision-making and evaluation processes. The goal of session four is to support the decision-making process. If applicable, the session begins with a review of the Family Disclosure Worksheet and all other intervention materials. The decision-making process is reviewed, and comfort and acceptance with each decision is again explored. Participants are encouraged to reflect on their readiness to make disclosure decisions with respect to specific family members. If the decision not to disclose is made, the session focus includes support of that decision, and a discussion of the cues for assessment and re-evaluation. Preliminary data from the pilot study suggest that disclosures were still occurring at 3-months post-intervention, indicating that a booster session may be helpful. In addition to initial exposure to "treatment," effective interventions generally include some follow-up or booster sessions to support durability of impact. Low frequency booster sessions following the termination of an intensive treatment have been proposed as one method that may assist in maintaining treatment gains, and have been shown to be effective for a variety of therapeutic interventions including behavioral family therapy, anger management, assertions skills training, behavioral psychotherapy, and HIV prevention. In this study a 3-month booster session will be used to reinforce the effects of the intervention through continued discussion of disclosure decisions in the preceding months, strategies used in disclosing, and rewards and costs of decision-making.
The Control condition is: Attention control case management (ACCM). The CDC's HIV Prevention case management program "Comprehensive Risk Counseling and Services" (CRCS) will be used to provide the attention-placebo control. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. HIV-positive individuals often have numerous psychosocial, financial, and medical challenges, and may not immediately acknowledge the need for prevention services because their basic living needs (e.g., housing) are more salient. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients. Trust is a key element in the ability to work with participants. In the ACCM, the facilitator will work in cooperation with the participant using a problem-solving approach geared to build trust, and will place emphasis on connecting the participant to community-based services and supports. As operationalized by the AIDS and Substance Abuse Program, the initial CRCS meeting provides an opportunity to describe the program, gather information and establish rapport. For those who present with immediate needs such as for shelter or medical care, this first meeting may provide an opportunity for linking the participant to services immediately. The initial treatment plan is developed in the second meeting. The facilitator will go through each of six general areas with the participant to gather a history and picture of the current situation: (1) substance abuse; (2) basic needs; (3) health care; (4) mental health; (5) legal issues; and (6) support systems. Once this review is complete, an initial intervention plan is developed with specific goals and objectives. Case management is a continual process of developing goals, working to meet those goals and addressing obstacles. Thus, the ACCM can mimic the experimental condition, and will be delivered on the same session schedule as the experimental condition and will include a comparable booster session at 3 months. Facilitators will be extensively trained by the PI and will be knowledgeable regarding local resources for HIV-positive persons. Facilitators will be qualified to make appropriate referrals to service providers and to local AIDS service organizations (ASOs), and will evaluate participant referral follow-through by encouraging a discussion of referral activities at each session. Resource lists provided to participants in both groups during the first session will include contact information for a 24-hour hotline in the event of emergency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maybe, Maybe Not | Experimental | Behavioral: Maybe, Maybe NotThe intervention is an individual-level 4-session + 3 month booster series designed to assist persons with HIV in making decisions regarding the disclosure of their HIV serostatus to family members. |
| Comprehensive Risk Counseling and Services | Active comparator | Behavioral: Comprehensive Risk Counseling and ServicesComprehensive Risk Counseling and Services (CRCS) will be used to provide the attention-placebo control (CDC, 2006). CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-positive men and women
- over the age of 18
- indicate an interest in learning more about disclosure
- have at least one family member who does not know of diagnosis
- sexually active in past 90 days
Key exclusion criteria (5 listed)
- not HIV-positive
- children under the age of 18
- not able to speak and understand English
- do not plan on living in Tampa area for the year
- not sexually active in last 90 days
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 |
|---|---|---|
| Maybe, Maybe NotThe goals of session one are to introduce participants to the intervention, to assess current decision context, to assist in the clarification of participant values, and to encourage the participant to set specific goals for disclosure decision-making. The goals for session two are to explore the participants' motivations to disclose or not to disclose and the potential costs and rewards of both disclosing and not disclosing. The goals for session three are to guide participants through disclosure decision making, and to support comfort/acceptance with decisions made. The goal of session four is to support the decision-making process. The booster session is used to reinforce the effects of the intervention through continued discussion of disclosure decisions in the preceding months, strategies used in disclosing, and rewards and costs of decision-making. | Behavioural | Maybe, Maybe Not |
| Comprehensive Risk Counseling and ServicesAlso: CRCSCRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs.CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients. | Behavioural | Comprehensive Risk Counseling and Services |
Primary outcome
Change from baseline to 52 weeks in HIV Transmission Risk
Time frame: Baseline, Week 7, Week 12, Week 24, Week 52
Ordinal measure of HIV transmission risk. The ordinal measure is constructed from information provided by the participant on the last five sexual encounters during the prior 30 days, with the highest risk assigned to encounters involving discordant anal/vaginal intercourse, unprotected, with a discordant partner (XEF)
3 secondary outcomes
Change from baseline to 52 weeks in the number of family members to whom participants have disclosed their positive serostatus
Time frame: Baseline, Week 7, Week 12, Week 24, Week 52
Change from baseline to 52 weeks in the odds of disclosure to sex partners
Time frame: Baseline, Week 7, Week 12, Week 24, Week 52
Change from baseline to 52 weeks in the proportion of sex partners disclosed to
Time frame: Baseline, Week 7, Week 12, Week 24, Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
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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.
Julianne M Serovich, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maybe, Maybe Not and Comprehensive Risk Counseling and Services in people with HIV Risk Reduction and Attention Control Case Management, run by University of South Florida at 1 site in United States.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
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?
Change from baseline to 52 weeks in HIV Transmission Risk (time frame: Baseline, Week 7, Week 12, Week 24, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2020.