- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040841
Supporting Sustained HIV Treatment Adherence After Initiation (SUSTAIN)
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: S2/Peer: Enhanced peer group support
- Behavioral: S1/Text: Weekly check-in texts
- Behavioral: M3/EAM: Immediate outreach to subject after EAM-identified missed doses
- Behavioral: M2/PRM: Immediate outreach to subject after a missed pharmacy refill
- Behavioral: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result
Detailed Description
The study's primary research goal is to identify the optimal combination of evidence-based and scalable HIV interventions for low-resource, high-burden settings. The investigators propose to 1) test the relative contribution of five promising intervention components; 2) collect cost and other implementation data; and 3) create a multi-component intervention package to optimize cost-effectiveness and implementation success. Of the five components, three are methods of non-adherence detection plus patient outreach; two are adherence support methods that can be integrated into Cape Town healthcare systems. These will not overcome all challenges that ART patients experience (e.g., structural barriers such as food insecurity) but they represent scalable, feasible, acceptable, and effective options. Notably, they are all behavioral approaches grounded in the experience and priorities of local health officials with whom the investigators have worked to identify scaleable interventions. While the study will be in Cape Town, it is broadly adaptable to other resource-limited settings.
The gold standard for testing interventions is the randomized controlled trial (RCT), which minimizes bias when testing cause and effect of a new exposure. When testing an intervention with more than one element, however, untangling the effect of individual elements is impossible. Indeed, data on the performance of individual components and their interactions-critical for developing and refining the components of a packaged intervention-is lost in an RCT. Notably, clinical care typically relies on packages of services, not single interventions, and packaged interventions are recommended for ART support. An effective way to test a multi-component intervention is to use the novel Multiphase Optimization STrategy (MOST), an engineering-inspired method for identifying the most efficacious combination of components in a packaged intervention, thus allowing researchers to drop inactive or weakly-performing components and construct an optimized package based on effect, cost, and other features. Once the optimized multi-component intervention is chosen, an RCT or quasi-experiment can follow to determine whether the optimized package yields superior outcomes compared to existing standards. MOST encompasses three phases: 1) preparation; 2) optimization; and 3) evaluation, often in an RCT. In this project, we have completed preparation, including a pilot study in Cape Town. SUSTAIN will comprise the middle optimization phase. The evaluation phase will be the focus of a future study.
The specific aims are:
Aim 1. Employ a highly efficient fractional factorial design to determine the effects of five intervention components on the primary outcome (HIV viral suppression) and secondary outcomes (ART adherence measured by EAM, ART retention per clinic records, days of unsuppressed virus, time to nonadherence detection, and time to linkage to support). The investigators will explore effect mechanisms quantitatively and qualitatively.
Aim 2. Evaluate the intervention components to address implementation, service, and client outcomes according to the Proctor framework. Data collection will involve tracking of intervention component use, time and motion studies, and quantitative surveys and qualitative interviews with participants and staff.
Aim 3. Use the effectiveness data collected in Aim 1 and the implementation and client outcomes in Aim 2 to model the multi-component intervention optimized for cost-effectiveness and implementation success.
Study Summary This study is designed to advance the translation of evidence-based interventions into clinical settings to benefit patients. There is ample evidence on what works to support ART adherence and retention-much of it from our own research. The investigators partnered with local officials and clinical staff in Cape Town to review the evidence and to conduct formative research to identify the most effective, acceptable, and feasible intervention options for patients and providers. The proposed study represents the next critical step: the investigators will test the intervention components that emerged from the formative work, encompassing elements to both rapidly identify nonadherent patients and to strengthen the support they receive once identified, to provide the data needed to construct the most cost-effective and sustainable multi-component intervention. The choice of intervention components will allow a critical test of advanced monitoring technology compared to simpler tools to identify nonadherence. By using an innovative MOST design to guide collection and analysis of efficacy, cost, and other implementation data, the study aligns with NIH's goals of using novel scientific methods to advance implementation science.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lora Sabin, PhD MA
- Phone Number: +16179218864
- Email: lsabin@bu.edu
Study Contact Backup
- Name: Catherine Orrell, MBChB PhD
- Phone Number: +27834561969
- Email: catherine.orrell@hiv-research.org.za
Study Locations
-
-
Western Cape
-
Cape Town, Western Cape, South Africa
- Recruiting
- Mzamomhle
-
Contact:
- Lauren Jennings, MD
- Email: Lauren.Jennings@hiv-research.org.za
-
Cape Town, Western Cape, South Africa
- Recruiting
- Phumlani
-
Contact:
- Lauren Jennings, MD
- Email: Lauren.Jennings@hiv-research.org.za
-
Cape Town, Western Cape, South Africa
- Recruiting
- Weltevreden Valley
-
Contact:
- Lauren Jennings
- Email: Lauren.Jennings@hiv-research.org.za
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria - Main study:
- Adults (≥18 years) and adolescents 16-17 years.
- HIV-positive and attending a local City of Cape Town (COCT) clinic to commence ART.
- Able to provide full informed consent, with a written signature. For those who are illiterate, a witness will be present throughout the process and will sign the form, while the participant will add their right thumb print. For those who are aged 16-17 years, informed written assent will be obtained, and the adolescent must have a parent or guardian who can provide full informed consent (see **below for how parent/guardian is defined for this purpose).
- Access to a working cellphone and willingness to receive study-related messaging on that phone.
- Willingness to comply with study procedures, including providing regular updates of contact details /locator information, and use a EAM device for the duration of participation.
Other Inclusion Criteria:
Aim 1: In-depth interviews (IDIs) with subset of trial subjects at baseline and months 12 and 24.
- Participation in the main trial.
- Self-reported prior experience with substance use, depression, gender inequity, stigma, or transport/clinic issues.
Aim 2: Questionnaires and IDIs with staff members at study clinics (three total clinics).
- Adults (≥18 years)
- Staff at study clinics, providing HIV care and/or treatment.
Aim 2: Focus group discussion (FGD) with City of Cape Town officials.
- Adults (≥18 years)
- Staff at City of Cape Town.
Exclusion Criteria - Main study:
- Clinical conditions as assessed by the COCT clinic clinicians at first visit e.g. renal disease, which preclude the use of a single tablet regimen (with the exception of those on tuberculosis (TB) treatment who are required to take an extra dose of dolutegravir daily).
- Planning to leave Cape Town permanently within the next 24 months.
- Being perinatally infected with HIV. Being infected from birth typically means a set of experiences and complications at a young age that require unique and special attention.
- If an adolescent, taking their ART medication as a syrup, as they are required to use the electronic adherence monitor (Wisepill device), which is only suitable for tablets.
Other Inclusion Criteria:
Aim 1: IDIs with trial subjects.
• None.
Aim 2: Questionnaires and IDIs with staff members at clinics. • None.
Aim 2: FGD with City of Cape Town officials.
• None.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Condition 1
Includes 1 intervention: S2/Peer: Enhanced peer group support. |
Subject will receive an enhanced form of peer group support.
Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version.
"Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
Other Names:
|
Experimental: Condition 2
Includes 1 intervention: S1/Text: Weekly check-in text messages. |
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics.
Subjects will be sent weekly simple but supportive text messages e.g.
"how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Other Names:
|
Experimental: Condition 3
Includes 1 intervention: M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient. |
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor).
There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
|
Experimental: Condition 4
Includes 3 interventions: M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support. |
Subject will receive an enhanced form of peer group support.
Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version.
"Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
Other Names:
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics.
Subjects will be sent weekly simple but supportive text messages e.g.
"how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Other Names:
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor).
There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
|
Experimental: Condition 5
Includes 1 intervention: M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient. |
The subject will be contacted if he/she fails to collect medication from the pharmacy.
A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support.
There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
|
Experimental: Condition 6
Includes 3 interventions: M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support. |
Subject will receive an enhanced form of peer group support.
Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version.
"Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
Other Names:
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics.
Subjects will be sent weekly simple but supportive text messages e.g.
"how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Other Names:
The subject will be contacted if he/she fails to collect medication from the pharmacy.
A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support.
There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
|
Experimental: Condition 7
Includes 3 interventions: M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support. |
Subject will receive an enhanced form of peer group support.
Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version.
"Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
Other Names:
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor).
There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
The subject will be contacted if he/she fails to collect medication from the pharmacy.
A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support.
There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
|
Experimental: Condition 8
Includes 3 interventions: M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages. |
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics.
Subjects will be sent weekly simple but supportive text messages e.g.
"how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Other Names:
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor).
There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
The subject will be contacted if he/she fails to collect medication from the pharmacy.
A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support.
There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
|
Experimental: Condition 9
Includes 1 intervention: M1/OTR: Outreach (OTR) to patient due to unsuppressed VL test result. |
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter.
Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend.
For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support.
There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Other Names:
|
Experimental: Condition 10
Includes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support. |
Subject will receive an enhanced form of peer group support.
Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version.
"Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
Other Names:
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics.
Subjects will be sent weekly simple but supportive text messages e.g.
"how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Other Names:
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter.
Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend.
For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support.
There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Other Names:
|
Experimental: Condition 11
Includes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support. |
Subject will receive an enhanced form of peer group support.
Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version.
"Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
Other Names:
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor).
There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter.
Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend.
For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support.
There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Other Names:
|
Experimental: Condition 12
Includes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages. |
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics.
Subjects will be sent weekly simple but supportive text messages e.g.
"how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Other Names:
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor).
There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter.
Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend.
For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support.
There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Other Names:
|
Experimental: Condition 13
Includes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S2/Peer: Enhanced peer group support. |
Subject will receive an enhanced form of peer group support.
Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version.
"Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
Other Names:
The subject will be contacted if he/she fails to collect medication from the pharmacy.
A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support.
There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter.
Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend.
For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support.
There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Other Names:
|
Experimental: Condition 14
Includes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S1/Text: Weekly check-in text messages. |
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics.
Subjects will be sent weekly simple but supportive text messages e.g.
"how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Other Names:
The subject will be contacted if he/she fails to collect medication from the pharmacy.
A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support.
There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter.
Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend.
For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support.
There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Other Names:
|
Experimental: Condition 15
Includes 3 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient. |
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor).
There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
The subject will be contacted if he/she fails to collect medication from the pharmacy.
A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support.
There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter.
Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend.
For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support.
There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Other Names:
|
Experimental: Condition 16
Includes 5 interventions: M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support. |
Subject will receive an enhanced form of peer group support.
Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version.
"Enhanced" peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks.
Other Names:
Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics.
Subjects will be sent weekly simple but supportive text messages e.g.
"how are you?" with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent.
Other Names:
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor).
There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
The subject will be contacted if he/she fails to collect medication from the pharmacy.
A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support.
There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
Other Names:
Standard of care viral loads are drawn at month 4, month 12 and annually thereafter.
Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the "Risk of Treatment Failure" (ROTF) clinic for adherence support when they next attend.
For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support.
There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV viral suppression at 24 months
Time Frame: 24 months
|
This outcome will measure the effect of the interventions on HIV viral suppression from enrollment to the end of study participation.
HIV viral suppression will be defined as % plasma viral load (VL) <50 copies/mL (dichotomous).
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV viral suppression at 12 months
Time Frame: 12 months
|
This outcome will be an intermediary outcome measure performed half-way through study participation.
HIV viral suppression will be defined as % plasma VL <50 copies/mL (dichotomous).
|
12 months
|
Change in HIV viral load between baseline and 12 months
Time Frame: baseline, 12 months
|
This will measure the effect on HIV viral load of exposure to interventions during the first half of study participation.
It will be measured as the change in HIV viral load, defined as the mean change in HIV plasma between month 0 and month 12 post-enrollment (continuous).
|
baseline, 12 months
|
Change in HIV viral load between baseline and 24 months
Time Frame: baseline, 24 months
|
This will measure the effect on HIV viral load of exposure to interventions over the entire course of study participation.
It will be measured as the change in HIV viral load, defined as the mean change in HIV plasma between month 0 and month 24 post-enrollment (continuous).
|
baseline, 24 months
|
Days of unsuppressed virus between baseline and 24 months
Time Frame: baseline, 24 months
|
This measure will determine the days that subjects experience unsuppressed virus, measured between baseline and the end of the study at 24 months (continuous).
|
baseline, 24 months
|
Achievement of ≥ 90% adherence in month 24
Time Frame: month 24
|
This measure indicates whether subject achieved adherence of 90% or more during the final month of study participation in month 24 (dichotomous).
|
month 24
|
Mean adherence from baseline through 24 months
Time Frame: baseline through 24 months
|
This measure indicates mean adherence over the entire length of the study from enrollment through 24 months (continuous).
|
baseline through 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lora Sabin, PhD, MA, Boston University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- H-41920
- 1R01MH125703-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on HIV Infections
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University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
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University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
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Gérond'ifRecruiting
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University of California, DavisCompleted
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University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
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University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
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HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
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University of ZimbabweCompleted
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Florida International UniversityCompleted
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Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on S2/Peer: Enhanced peer group support
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US Department of Veterans AffairsCompleted
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University of WashingtonNational Institute of Mental Health (NIMH); Kenyatta National HospitalActive, not recruitingPlanning the mPACT Trial - mHealth Strategies for the Pediatric to Adult HIV Care Transition (mPACT)Transition From Pediatric to Adult HIV CareKenya
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University of Texas at AustinNot yet recruitingMilitary FamilyUnited States
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Danish Cancer SocietyTrygFonden, Denmark; IMK Almene FondCompleted
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Africa Health Research InstituteCompleted
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Elizabeth Glaser Pediatric AIDS FoundationMinistry of Health and Child Welfare, Zimbabwe; The Children's Investment Fund...CompletedHIV-infection/Aids
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University of WashingtonPatient-Centered Outcomes Research InstituteRecruitingEndometrial CancerUnited States
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Northwestern UniversityCompletedDepressionUnited States
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Seattle Children's HospitalNot yet recruiting
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University of California, San FranciscoPatient-Centered Outcomes Research InstituteCompleted