CouplesNCT02335138
Project Nexus: Providing Online Counseling for Home-Based HIV Testing
A study testing Couples HIV Testing and Counseling (CHTC, CVCT) and at-home test kit in people with Couples, run by University of Michigan at 1 site in United States.
Trial summary
The proposed research aims to address the question: Compared to the current standard of care for home-based HIV tests, in which persons conduct and interpret HIV tests without counseling, does the addition of video conferencing with a remote counselor increase health-enhancing, protective behaviors among male-male… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Couples
- What is being tested?
- Couples HIV Testing and Counseling (CHTC, CVCT) and at-home test kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 30 Sep 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male sex at birth
- Male gender
- 18 or older
- In a relationship with a male sexual partner of duration six months or longer
- Negative or unknown HIV status and not having tested in the last 6 months, with a partner meeting the same criteria OR in a sero-discordant with the negative/unknown partner reporting not having tested in the past 6 months
- No recent (past year) severe intimate partner violence (IPV) reported within the couple. IPV will be determined by responses to the below questions, in addition to parallel questions addressing perpetration of the specified acts:
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- Excluding consensual acts such as mutually agreed upon BDSM, in the past year, how many times has [your partner] punched, hit, or slapped you?
- Excluding consensual acts such as mutually agreed upon BDSM, in the past year, how many times has [your partner] kicked you?
- Excluding consensual acts such as mutually agreed upon BDSM, in the past year, how many times has [your partner] used force or threats of force to make you do something sexual that you didn't want to do?
- Excluding consensual acts such as mutually agreed upon BDSM, in the past year, how many times has [your partner] raped you? [Follow up question: Do you feel safe in your relationship?]
- Willingness to have HIV test kits delivered to a home address they provide
- Willingness to be tested for HIV with one's male sexual partner
- Willingness to be randomized to either study arm
- Willingness and ability to participate in video-based counseling (must have a computer or tablet with video and audio capabilities, Internet access)
Who cannot join
- Sex at birth other than male
- Gender other than male
- Either partner aged 17 or younger
- Does not have a main male sex partner or has a main male sex partner of relationship duration less than 6 months
- Both partners within the couple report known, positive HIV status OR one or both partners reports having tested negative for HIV within 6 months
- Either partner reports experiencing or perpetrating intimate partner violence within the couple within the past year
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- Either partner expresses unwillingness to have HIV test kits delivered to a home address
- Either partner expresses unwillingness to test for HIV together with his male sexual partner
- Either partner expresses unwillingness to be randomized
- Unwillingness or inability to participate in video-based counseling
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Center for Sexuality & Health Disparities (SexLab)
Ann Arbor, Michigan, 48109
About this study
The proposed research aims to address the question: Compared to the current standard of care for home-based HIV tests, in which persons conduct and interpret HIV tests without counseling, does the addition of video conferencing with a remote counselor increase health-enhancing, protective behaviors among male-male couples and facilitate linkage to care for those who test positive?
Read the detailed description
The investigators propose to address four specific aims through a randomized controlled trial (RCT) to take place over a four-year period. The investigators plan to enroll and maintain a cohort of 350 men who have sex with men (MSM) couples: 175 self-reported concordant HIV-negative and 175 self-reported HIV-discordant couples. Within this sample, the proposed study will examine the impact of home-testing with video-based Couples HIV Testing and Counseling (CHTC) (intervention) versus home-testing alone (control) on changes in: sexual risk-taking (e.g., UAI), formation and adherence to explicit agreements about sex, relationship functioning for the management of HIV risk, and linkage to care for newly diagnosed HIV positives among MSM couples who live throughout the US. To assess these specific changes, couples will complete online surveys at 3 time points (baseline, 3 months and 6 months).
- Conditions
- Couples
- Being tested
- Couples HIV Testing and Counseling (CHTC, CVCT), at-home test kit
- Keywords
- HIV, MSM, Couples, Home Testing, Sexual Agreements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples HIV Testing and Counseling (CHTC, CVCT)Behavioural
Also called CHTC, CVCT
Male couples randomized to the experimental group (Couples HIV Testing and Counseling, CHTC/CVCT) will receive HIV counseling and testing as a couple via an online, HIPPA-compliant videoconferencing service. The dyad-centered session will last less than one hour and focus on couples agreement, prevention strategies, and/or linkage to HIV care, depending on each couple's test results. Participants will complete follow-up surveys at 3 and 6 months post-testing.
at-home test kitBehavioural
Male couples in the control group will receive test kits, but will not receive any testing intervention. Once individual results are reported,participants will be contacted via phone by study staff with options for referrals to services for the reactive partner(s). Participants will complete follow-up surveys at 3 and 6 months post-testing.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Each participant will receive an at-home test kit and will be asked to test and return results to investigator. Receives: Behavioral: at-home test kit |
| Intervention Arm | Active comparator | Each participant will receive an at-home test kit and will be asked to take the test in conjunction with an online CHTC session. Receives: Behavioral: Couples HIV Testing and Counseling (CHTC, CVCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Process and use of communal coping - Outcome Efficacy to Reduce HIV Threat
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. We created three subscales to capture the full range of outcome efficacy related to these three processes of communal coping. For the first subscale, Joint Effort, we used the stem, "My partner and I believe that 'working together' versus on our own is an effective strategy;" for the second subscale, Communication, we used the stem, "Communicating with my partner is an effective strategy for;" and for the third subscale, Planning and Decision-making, we used the stem, "My partner and I making decisions together rather than separately is an effective strategy." The items for each of the three subscales were the same as the items used for the Preference for Sexual Health Outcomes scale.
Measured: 6 months
Process and use of communal coping - Couple Efficacy to Reduce HIV Threat
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. Couple efficacy is defined as a couple's confidence that together they can engage in communal coping efforts. We developed three subscales in parallel to Outcome Efficacy to Reduce HIV Threat Scale: Joint Effort, Communication, and Planning and Decision-making.
Measured: 6 months
Process and use of communal coping - Communal Coping to Reduce HIV Threat
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. Scale: We developed three subscales in parallel to the Outcome Efficacy Scale and the Couple Efficacy Scale: Joint Effort, Communication, and Planning and Decision-making. All three subscales used the same six items from these other scales to capture the managing of reducing the health threat of HIV, but the stems were different.
Measured: 6 months
Changes in Sexual Agreements
We measure changes in sexual agreements using questions from previous studies of MSM couples' sexual agreements. Participants will be asked which of the following best describes their current sexual agreement with their main partner: "both of us cannot have sex with outside partners," "we can have sex with outside partners, without any conditions or restrictions," "we can have sex with outside partners, but with conditions or restrictions," and "we do not have an agreement." Additional items about agreements will further assess whether couples permitted (or did not permit) that certain sexual behaviors, namely UAI and oral sex, could occur with outside partners. In follow-up surveys, participants will be asked whether their agreement changed, and if so, to re-categorize their agreement type.
Measured: 6 months
Changes in Sexual Behavior
We measure changes in sexual behavior using behavioral measures adapted from the NHBS behavioral inventory and previously used with thousands of MSM by our team will collect information both on sexual behaviors with the main sex partner in the 3 months before the interview, and on sexual behaviors with all sex partners outside the relationship. For sex with the main partner, men will be asked to estimate the number of anal sex acts with the main partner, and the number of those acts that were condom-protected. For outside the relationship, we will ask a series of questions about each outside partner, including HIV status of that partner (if known), whether the sex outside the relationship was disclosed to the main partner, the number and type of sex acts with each outside partner, and the proportion of those sex acts that were protected by condoms.
Measured: 6 months
Secondary outcomes (1)
Linkage to Care
We will measure linkage to care with the following outcomes as indicators per the recent recommendations of the Institute of Medicine: within 3 months of HIV diagnosis (1) attending at least one clinical care appointment, (2) having at least one CD4 test performed, and (3) having at least one viral load test performed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startApr 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CouplesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, University of Rochester
- Responsible party
- Principal investigator, Robert Stephenson, University of Michigan
- Investigators
- Rob Stephenson, PhD, Principal investigator, University of Michigan School of Nursing Department of Health Behavior and Biological Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335138
- Sponsor's protocol ID
- IRB00072655
- Status last verified
- Oct 2019
- First submitted
- 7 Jan 2015
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Stephenson R, Freeland R, Sullivan SP, Riley E, Johnson BA, Mitchell J, McFarland D, Sullivan PS. Home-Based HIV Testing and Counseling for Male Couples (Project Nexus): A Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 May 30;6(5):e101. doi: 10.2196/resprot.7341.
PubMed 28559225
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Nexus: Providing Online Counseling for Home-Based HIV Testing
- ClinicalTrials.gov ID
- NCT02335138
- Acronym / sponsor ID
- IRB00072655
- Conditions
- Couples
- Keywords
- HIV, MSM, Couples, Home Testing, Sexual Agreements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Miami, University of Rochester
- Study start
- Apr 2016
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 9 Jan 2015 (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 proposed research aims to address the question: Compared to the current standard of care for home-based HIV tests, in which persons conduct and interpret HIV tests without counseling, does the addition of video conferencing with a remote counselor increase health-enhancing, protective behaviors among male-male couples and facilitate linkage to care for those who test positive?
Detailed description
The investigators propose to address four specific aims through a randomized controlled trial (RCT) to take place over a four-year period. The investigators plan to enroll and maintain a cohort of 350 men who have sex with men (MSM) couples: 175 self-reported concordant HIV-negative and 175 self-reported HIV-discordant couples. Within this sample, the proposed study will examine the impact of home-testing with video-based Couples HIV Testing and Counseling (CHTC) (intervention) versus home-testing alone (control) on changes in: sexual risk-taking (e.g., UAI), formation and adherence to explicit agreements about sex, relationship functioning for the management of HIV risk, and linkage to care for newly diagnosed HIV positives among MSM couples who live throughout the US. To assess these specific changes, couples will complete online surveys at 3 time points (baseline, 3 months and 6 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Behavioral: at-home test kitEach participant will receive an at-home test kit and will be asked to test and return results to investigator. |
| Intervention Arm | Active comparator | Behavioral: Couples HIV Testing and Counseling (CHTC, CVCT)Each participant will receive an at-home test kit and will be asked to take the test in conjunction with an online CHTC session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male sex at birth
- Male gender
- 18 or older
- In a relationship with a male sexual partner of duration six months or longer
- Negative or unknown HIV status and not having tested in the last 6 months, with a partner meeting the same criteria OR in a sero-discordant with the negative/unknown partner reporting not having tested in the past 6 months
Key exclusion criteria (10 listed)
- Sex at birth other than male
- Gender other than male
- Either partner aged 17 or younger
- Does not have a main male sex partner or has a main male sex partner of relationship duration less than 6 months
- Both partners within the couple report known, positive HIV status OR one or both partners reports having tested negative for HIV within 6 months
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 |
|---|---|---|
| Couples HIV Testing and Counseling (CHTC, CVCT)Also: CHTC, CVCTMale couples randomized to the experimental group (Couples HIV Testing and Counseling, CHTC/CVCT) will receive HIV counseling and testing as a couple via an online, HIPPA-compliant videoconferencing service. The dyad-centered session will last less than one hour and focus on couples agreement, prevention strategies, and/or linkage to HIV care, depending on each couple's test results. Participants will complete follow-up surveys at 3 and 6 months post-testing. | Behavioural | Intervention Arm |
| at-home test kitMale couples in the control group will receive test kits, but will not receive any testing intervention. Once individual results are reported,participants will be contacted via phone by study staff with options for referrals to services for the reactive partner(s). Participants will complete follow-up surveys at 3 and 6 months post-testing. | Behavioural | Control Arm |
Primary outcome
Process and use of communal coping - Outcome Efficacy to Reduce HIV Threat
Time frame: 6 months
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. We created three subscales to capture the full range of outcome efficacy related to these three processes of communal coping. For the first subscale, Joint Effort, we used the stem, "My partner and I believe that 'working together' versus on our own is an effective strategy;" for the second subscale, Communication, we used the stem, "Communicating with my partner is an effective strategy for;" and for the third subscale, Planning and Decision-making, we used the stem, "My partner and I making decisions together rather than separately is an effective strategy." The items for each of the three subscales were the same as the items used for the Preference for Sexual Health Outcomes scale.
Process and use of communal coping - Couple Efficacy to Reduce HIV Threat
Time frame: 6 months
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. Couple efficacy is defined as a couple's confidence that together they can engage in communal coping efforts. We developed three subscales in parallel to Outcome Efficacy to Reduce HIV Threat Scale: Joint Effort, Communication, and Planning and Decision-making.
Process and use of communal coping - Communal Coping to Reduce HIV Threat
Time frame: 6 months
Based on Lewis's model Couple's Interdependence Theory, we will measure process and use of communal coping or how couples work together and make decisions together to reduce the health threat. Scale: We developed three subscales in parallel to the Outcome Efficacy Scale and the Couple Efficacy Scale: Joint Effort, Communication, and Planning and Decision-making. All three subscales used the same six items from these other scales to capture the managing of reducing the health threat of HIV, but the stems were different.
Changes in Sexual Agreements
Time frame: 6 months
We measure changes in sexual agreements using questions from previous studies of MSM couples' sexual agreements. Participants will be asked which of the following best describes their current sexual agreement with their main partner: "both of us cannot have sex with outside partners," "we can have sex with outside partners, without any conditions or restrictions," "we can have sex with outside partners, but with conditions or restrictions," and "we do not have an agreement." Additional items about agreements will further assess whether couples permitted (or did not permit) that certain sexual behaviors, namely UAI and oral sex, could occur with outside partners. In follow-up surveys, participants will be asked whether their agreement changed, and if so, to re-categorize their agreement type.
Changes in Sexual Behavior
Time frame: 6 months
We measure changes in sexual behavior using behavioral measures adapted from the NHBS behavioral inventory and previously used with thousands of MSM by our team will collect information both on sexual behaviors with the main sex partner in the 3 months before the interview, and on sexual behaviors with all sex partners outside the relationship. For sex with the main partner, men will be asked to estimate the number of anal sex acts with the main partner, and the number of those acts that were condom-protected. For outside the relationship, we will ask a series of questions about each outside partner, including HIV status of that partner (if known), whether the sex outside the relationship was disclosed to the main partner, the number and type of sex acts with each outside partner, and the proportion of those sex acts that were protected by condoms.
1 secondary outcome
Linkage to Care
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Derived from this study: PubMed 28559225Stephenson R, Freeland R, Sullivan SP, Riley E, Johnson BA, Mitchell J, McFarland D, Sullivan PS. Home-Based HIV Testing and Counseling for Male Couples (Project Nexus): A Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 May 30;6(5):e101. doi: 10.2196/resprot.7341.
- Individual participant dataSharing planned: No
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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.
Rob Stephenson, PhD principal investigator
University of Michigan School of Nursing Department of Health Behavior and Biological Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples HIV Testing and Counseling (CHTC, CVCT) and at-home test kit in people with Couples, run by University of Michigan 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 14 inclusion and 10 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 21 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Process and use of communal coping - Outcome Efficacy to Reduce HIV Threat (time frame: 6 months). The study lists 5 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 NCT02335138, which also lists 1 linked publication.
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 21 Oct 2019.