Project Nexus: Providing Online Counseling for Home-Based HIV Testing
2019年10月18日 更新者：Robert Stephenson、University of Michigan
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?
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (実際)
800
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Center for Sexuality & Health Disparities (SexLab)
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
Inclusion Criteria:
- 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:
- 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)
Exclusion Criteria:
- 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
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Control Arm
Each participant will receive an at-home test kit and will be asked to test and return results to investigator.
|
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.
|
|
アクティブコンパレータ：Intervention Arm
Each participant will receive an at-home test kit and will be asked to take the test in conjunction with an online CHTC session.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Process and use of communal coping - Outcome Efficacy to Reduce HIV Threat
時間枠：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.
|
6 months
|
|
Process and use of communal coping - Couple Efficacy to Reduce HIV Threat
時間枠：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.
|
6 months
|
|
Process and use of communal coping - Communal Coping to Reduce HIV Threat
時間枠：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.
|
6 months
|
|
Changes in Sexual Agreements
時間枠：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.
|
6 months
|
|
Changes in Sexual Behavior
時間枠：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.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Linkage to Care
時間枠：6 months
|
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.
|
6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Predisposing couple factors - Perceived Severity of HIV
時間枠：6 months
|
Based on Lewis's model Couple's Interdependence Theory, we will measure predisposing couple factors one of which will be Perceived Severity of HIV scale.
This construct involves the perception of the personal, psychosocial, and physical consequences of a particular health threat.
We developed a total of 13 items that crossed three pertinent domains: personal, psychosocial and physical.
|
6 months
|
|
Predisposing couple factors - Preferences for General Lifestyle
時間枠：6 months
|
Based on Lewis's model Couple's Interdependence Theory, we will measure predisposing couple factors.
One factor of interest will be Preferences for General Lifestyle scale which includes 6 outcomes including diet and nutrition and social activities.
|
6 months
|
|
Predisposing couple factors - Preferences for General Sexual Health
時間枠：6 months
|
Based on Lewis's model Couple's Interdependence Theory, we will measure predisposing couple factors.
One factor of interest will be Preferences for Sexual Health Outcomes scale which relates to sexual health, for example, reducing your risk for HIV.
|
6 months
|
|
Predisposing couple factors - Conflict Style
時間枠：6 months
|
Based on Lewis's model Couple's Interdependence Theory, we will measure predisposing couple factors.
One factor of interest is Conflict Style which would determine how respondents typically handle conflict in their relationships using the Conflict Style Inventory.
|
6 months
|
|
Predisposing couple factors - Communication Style
時間枠：6 months
|
Based on Lewis's model Couple's Interdependence Theory, we will measure predisposing couple factors.
One factor of interest is Communication Style which would determine how respondents typically handle conflict in their relationships using the Conflict Style Inventory.
|
6 months
|
|
Predisposing couple factors - Problem-solving Skills
時間枠：6 months
|
Based on Lewis's model Couple's Interdependence Theory, we will measure predisposing couple factors.
One factor of interest is Problem-solving Skills which will be measured with the adherence problem solving / readiness scale.
|
6 months
|
|
Partner's transformation of motivation - Emotional Response
時間枠：6 months
|
Based on Lewis's model Couple's Interdependence Theory, we will measure partner's transformation of motivation or the ability of the participants to respond (1) cognitively and (2) emotionally to the health threat.
The scale for emotional response includes whether the respondent reports being fearful, nervous, or anxious about HIV.
|
6 months
|
|
Partner's transformation of motivation - Cognitive Response
時間枠：6 months
|
Based on Lewis's model Couple's Interdependence Theory, we will measure partner's transformation of motivation or the ability of the participants to respond (1) cognitively and (2) emotionally to the health threat.
The scale for cognitive response includes whether the respondent reports understanding the risks of HIV transmission associated with being in a sero-discordant relationship, and the risks associated with outside sex partners.
|
6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Rob Stephenson, PhD、University of Michigan School of Nursing Department of Health Behavior and Biological Sciences
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年4月1日
一次修了 (実際)
2019年9月30日
研究の完了 (実際)
2019年9月30日
試験登録日
最初に提出
2015年1月7日
QC基準を満たした最初の提出物
2015年1月8日
最初の投稿 (見積もり)
2015年1月9日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月21日
QC基準を満たした最後の更新が送信されました
2019年10月18日
最終確認日
2019年10月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IRB00072655
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。