An interventional study of Incentivization based on high adherence and Incentivization based on timely clinic visit in HIV/AIDS, sponsored by RAND. Completed at 1 site in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by RAND · Not applicable, Interventional, and Treatment
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Among 121 studies in Acquired Immunodeficiency Syndrome with a site in Uganda — 17 open to participants now, 24 under way, 6 of them phase 3. Acquired Immunodeficiency Syndrome · Uganda.
Among the 121 studies in Acquired Immunodeficiency Syndrome with a site in Uganda, this one is the 55th largest by enrollment of the 103 interventional ones that give a count, is one of 6 that started in 2018, is one of 54 with no phase, and was the 65th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →17 of the 121 studies in Acquired Immunodeficiency Syndrome with a site in Uganda are open now. Recruiting first, the newest first:
University of California, San Francisco · Sites in Uganda
Ages 15+ · Women only · Healthy volunteers
ViiV Healthcare · Sites in Uganda, Romania, South Africa
Yale University · Sites in Uganda
Ages 18+
Yale University · Sites in Uganda
Ages 5–17 · Healthy volunteers
University of Washington · Sites in Uganda
Ages 15+ · Healthy volunteers
A study can be open while its sites in Uganda have not opened yet or have stopped. Only those recruiting at a site in Uganda →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
121 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 17 · Phase 3 23 · Phase 4 11
First in 2004; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 331 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 380 across the 103 interventional studies, 350 across the 18 observational. Of the 86 that completed or were terminated, 34 (40%) have results posted.
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14 of 121 have an industry lead sponsor. The 10 most frequent:
RAND is the lead sponsor of 115 studies on the registry; 7 are open to participants now.
RAND has 9 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Acquired Immunodeficiency Syndrome with a site in Uganda that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07071623Phase 3Merck Sharp & Dohme LLCA Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) | 2027-10-18 |
| NCT05373758Massachusetts General HospitalA Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa | 2027-06-30 |
| NCT07840651Makerere UniversityIntegrating Tuberculosis Treatment Into Community Pharmacies to Improve TB/HIV Outcomes in Uganda | 2027-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 121 studies in Acquired Immunodeficiency Syndrome with a site in Uganda, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.
It is imperative to find ways to boost ART adherence in sub-Saharan Africa where adherence rates have been found to decline over time, and where treatment options such as second-line regimens are limited. A promising tool is the use of incentives based on insights from behavioral economics (BE) for healthy HIV-related behavior. The proposed R01 study is based on the results of the PI's R34 'Rewarding Adherence Program (RAP)' [R34 MH096609] that demonstrated feasibility and acceptability of incentives allocated by a drawing for HIV-related behaviors, and established preliminary efficacy. The current R01 study builds on these promising results with the aim to a) use viral loads as biological endpoints that were not included in the R34 for cost reasons; b) establish efficacy in a fully powered intervention as well as comparative efficacy of two different ways of implementing the incentives including one arm that has been adapted to changing clinical guidelines and can be implemented with readily available data from clinic records; and c) assess the cost effectiveness of these two implementation modes as a further input for policy-makers. The intervention is targeted at increasing the motivation of HIV clients who have been on ART for several years through the benefit and joy of prize drawings, thereby attempting to overcome the treatment 'fatigue' that can develop in the context of mundane, daily pill taking over the course of life-long treatment. Insights from behavioral economics suggest that such an intervention may be particularly effective for people with present bias (those who have a tendency to give in to short-term temptation at the cost of more long-term benefits) that was found to be prevalent among HIV clients in the R34 study. The intervention will be implemented among 330 adult clients in three groups: for the first intervention group, timely clinic attendance will constitute the eligibility criteria for participating in a prize drawing at each scheduled clinic visit; participants are also eligible for an annual prize drawing based on showing viral suppression. The second treatment group will be incentivized on demonstrated high ART adherence between clinic visits that also determine the winning chances at an annual prize drawing. The control group will receive the usual standard of care. All participants will receive MEMS caps to record adherence and assessments over 24 months (at baseline and every 6 months thereafter). The first Specific Aim will be to evaluate the effectiveness of the intervention; the second aim is to compare the relative effectiveness of the adherence-based arm and the arm directly incentivizing viral suppression that uses only data readily available in the clinic. The third Specific Aim is to perform a comparative cost-effectiveness analysis of the two intervention arms as a further policy input. If proven efficacious, the intervention as implemented in the newly adapted arm based on viral load suppression can be readily taken over by the clinic and scaled at low cost to other clinics.
In the study also 70 treatment initiating clients (in addition to the 330 treatment mature clients described above) will be recruited, but they will be excluded from the main analysis. [Note on 9/7/2019: due to funding, we will not recruit this additional sample of treatment initiating clients]
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: for the 70 treatment initiators to be recruited in addition to the main sample of 330 treatment-mature clients (on which the main analysis will focus), the inclusion criteria are:
Exclusion Criteria:
Participants will be eligible for prize drawings at every regular clinic visit based on high adherence as measured by MEMS-caps. In addition there will be an annual prize drawing that is conditional on showing high adherence over the course of the year. This arm will receive the intervention 'Incentivization based on high adherence' and the intervention 'Annual adherence prize drawing' and (if eligible) the intervention 'Year 2 booster'. Note: the 70 treatment initiating clients will all be assigned to this arm to receive preliminary data as to whether incentives may work for this group.
Behavioral: Incentivization based on high adherence · Behavioral: Annual adherence prize drawing · Behavioral: Year 2 booster
Participants will be able to participate in prize drawings at every clinic visit where eligibility will be based on timely drug refills (that coincide with the clinic visits). Participants will also have a chance to enter a prize drawing at the end of every year if they show viral suppression. This arm will receive the intervention 'Incentivization based on timely clinic visit' and the intervention 'Annual viral suppression-based prize drawing', and (if eligible) the intervention 'Year 2 booster'.
Behavioral: Incentivization based on timely clinic visit · Behavioral: Annual viral suppression-based prize drawing · Behavioral: Year 2 booster
This arm will receive care as usual, including the adherence support mechanisms that are part of usual care practices.
When a participant comes for a regular clinic visit, s/he will have the MEMS data extracted, and if adherence over the previous month \>=90%, will participate in a prize drawing.
When a participant comes for a regular clinic visit on the day s/he is scheduled, s/he will participate in a prize drawing.
Participants will have a chance to take part in an annual drawing where eligibility is based on the average adherence during that year.
Participants will have a chance to take part in an annual drawing where eligibility is based on showing viral suppression.
Those participants not showing viral suppression at month 12 will be randomized in a 1:1 fashion to receive an additional intervention component or continue receiving the same intervention arm as in Year 1.
Electronically measured adherence
Number of ART doses taken / number of doses prescribed
Time frame: 12 months
Electronically measured adherence
Number of ART doses taken / number of doses prescribed
Time frame: 24 months
Viral suppression
Viral load \<=200 copies/mL
Time frame: At month 12
Viral suppression
Viral load \<=200 copies/mL
Time frame: At month 24
Plan to share: Undecided
Ran from Apr 2018 to primary completion in Oct 2023, 65 months.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 65 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →