Suppression of HIV 1 RNA in People Living With HIV
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/25/2018 |
| Start Date: | November 2015 |
| End Date: | March 2020 |
The investigators propose to evaluate a novel incentive intervention to promote suppression
of viral load in people living with HIV that will employ empirically-based parameters that
have been proven critical to the effectiveness of incentive interventions. Participants (N =
200) from medical clinics that serve adults living with HIV in Baltimore will be randomly
assigned to an Incentive or a Usual Care Control group. Incentive group participants will
receive incentives for maintaining suppressed and undetectable viral loads. The incentive
program will employ high magnitude incentives, provide incentives for decreases in viral load
early in treatment before a patient's viral load has reached undetectable levels, arrange
frequent incentives early in treatment and reduce the frequency of incentives as participants
achieve progressively longer periods of viral load suppression, arrange a schedule of
escalating incentives for sustained suppression of viral load, and the intervention will be
maintained for two years. Usual Care Control participants will only receive the standard HIV
medical care offered in their clinic. Assessments will be conducted every 3 months throughout
the two years of treatment and every 6 months throughout the year following treatment. The
primary outcome measure will be the percentage of participants that have undetectable viral
loads at the 3-month assessments conducted throughout the 2-year intervention period.
Secondary measures will include adherence to HIV care and post-treatment outcomes. The
investigators will also assess moderators and mediators of the effects of the incentives on
the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If
the incentive intervention maintains suppressed viral load and is economically sound, it
could be used to improve the health of adults living with HIV, reduce health care costs, and
reduce HIV transmission in the community.
of viral load in people living with HIV that will employ empirically-based parameters that
have been proven critical to the effectiveness of incentive interventions. Participants (N =
200) from medical clinics that serve adults living with HIV in Baltimore will be randomly
assigned to an Incentive or a Usual Care Control group. Incentive group participants will
receive incentives for maintaining suppressed and undetectable viral loads. The incentive
program will employ high magnitude incentives, provide incentives for decreases in viral load
early in treatment before a patient's viral load has reached undetectable levels, arrange
frequent incentives early in treatment and reduce the frequency of incentives as participants
achieve progressively longer periods of viral load suppression, arrange a schedule of
escalating incentives for sustained suppression of viral load, and the intervention will be
maintained for two years. Usual Care Control participants will only receive the standard HIV
medical care offered in their clinic. Assessments will be conducted every 3 months throughout
the two years of treatment and every 6 months throughout the year following treatment. The
primary outcome measure will be the percentage of participants that have undetectable viral
loads at the 3-month assessments conducted throughout the 2-year intervention period.
Secondary measures will include adherence to HIV care and post-treatment outcomes. The
investigators will also assess moderators and mediators of the effects of the incentives on
the suppression of viral load, and conduct cost-effectiveness and cost-benefit analyses. If
the incentive intervention maintains suppressed viral load and is economically sound, it
could be used to improve the health of adults living with HIV, reduce health care costs, and
reduce HIV transmission in the community.
Experimental Design. Participants (N = 200) will be randomly assigned to a Usual Care Control
group or the Incentive group. A computerized urn randomization procedure (Wei & Lachin, 1988)
will be used to balance groups on five baseline characteristics that may influence outcome:
(1) Diagnostic and Statistical Manual (DSM) V dependence on cocaine or opiates assessed on
the Composite International Diagnostic Interview (CIDI) (Y/N); (2) DSM V alcohol dependence
assessed on the CIDI (Y/N); (3) health literacy as assessed on the Test of Functional Health
Literacy in Adults (TOFHLA) (score ≤ the rolling median, Y/N); (4) impulsivity as assessed by
delay discounting (k value from the raw discounting data for each participant, which is an
index of impulsivity (≤ the rolling median of k, Y/N); and (5) depression as assessed by the
Beck Depression Inventory (score ≤ the rolling median, Y/N). Participants will be stratified
by DSM V cocaine, opiate and alcohol dependence, health literacy, and depression at intake
because drug use, health literacy, and depression has each been associated with poor
Anti-Retroviral Therapy (ART) adherence. Participants will be stratified based on measures of
impulsivity because high levels of impulsivity have been associated with poor health decision
making and adverse health behaviors.
Standard HIV Medical Care.
Upon enrollment, participants will be taught about the benefits of ART adherence and the need
to maintain nearly perfect adherence. All participants will receive their HIV medical care in
their clinic.
Incentive Group.
The Incentive group will receive the novel empirically-based incentive intervention to
promote long term suppression of HIV-1 RNA (viral load) being evaluated in this study. The
incentive intervention will employ features and parameters that have been shown critically
important to promote therapeutic behavior change in drug users and other populations.
participants will be taught the details of the incentive program with written instructions
and quizzes.
Usual Care Control Group.
Usual Care Control Only participants will receive the standard HIV medical care described
above offered in their medical clinic. Participants in this group will not receive added
viral load testing, feedback or incentives, beyond the viral load testing conducted as a
routine part of their medical care.
group or the Incentive group. A computerized urn randomization procedure (Wei & Lachin, 1988)
will be used to balance groups on five baseline characteristics that may influence outcome:
(1) Diagnostic and Statistical Manual (DSM) V dependence on cocaine or opiates assessed on
the Composite International Diagnostic Interview (CIDI) (Y/N); (2) DSM V alcohol dependence
assessed on the CIDI (Y/N); (3) health literacy as assessed on the Test of Functional Health
Literacy in Adults (TOFHLA) (score ≤ the rolling median, Y/N); (4) impulsivity as assessed by
delay discounting (k value from the raw discounting data for each participant, which is an
index of impulsivity (≤ the rolling median of k, Y/N); and (5) depression as assessed by the
Beck Depression Inventory (score ≤ the rolling median, Y/N). Participants will be stratified
by DSM V cocaine, opiate and alcohol dependence, health literacy, and depression at intake
because drug use, health literacy, and depression has each been associated with poor
Anti-Retroviral Therapy (ART) adherence. Participants will be stratified based on measures of
impulsivity because high levels of impulsivity have been associated with poor health decision
making and adverse health behaviors.
Standard HIV Medical Care.
Upon enrollment, participants will be taught about the benefits of ART adherence and the need
to maintain nearly perfect adherence. All participants will receive their HIV medical care in
their clinic.
Incentive Group.
The Incentive group will receive the novel empirically-based incentive intervention to
promote long term suppression of HIV-1 RNA (viral load) being evaluated in this study. The
incentive intervention will employ features and parameters that have been shown critically
important to promote therapeutic behavior change in drug users and other populations.
participants will be taught the details of the incentive program with written instructions
and quizzes.
Usual Care Control Group.
Usual Care Control Only participants will receive the standard HIV medical care described
above offered in their medical clinic. Participants in this group will not receive added
viral load testing, feedback or incentives, beyond the viral load testing conducted as a
routine part of their medical care.
Inclusion Criteria:
- living with HIV
Exclusion Criteria:
- report current suicidal or homicidal ideation;
- have a severe psychiatric disorder
We found this trial at
1
site
Baltimore, Maryland 21224
Phone: 410-550-2694
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