An interventional study of CAP-IT in HIV Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-20.
Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Not applicable, Interventional, and Treatment
Adherence to highly active antiretroviral therapy (HAART) is critical to successful treatment of HIV. This study tested an intervention that helps people infected with HIV take all their medications when and how they were supposed to.
People infected with HIV must take the regimen of highly active antiretroviral therapy (HAART) medications as prescribed to them, without missing doses, or they risk developing a resistant strain of the virus. Resistant strains of the virus do not respond to certain HAART regimens and are more dangerous for patients. Poor HAART adherence can lead to further HIV progression, more hospitalizations and opportunistic infections, and required use of second-line therapies. Interventions to increase adherence have had mixed success, with little data to support long-term effects and no one strategy emerging that provides consistent positive effects. The client adherence profiling and intervention tailoring (CAP-IT) program was first developed to increase adherence among people already on HAART with in-home nursing. This study modified CAP-IT to treat people newly on HAART and then tested whether this modified CAP-IT improved long-term HAART adherence.
This study included two stages. The first stage consisted of two focus groups, one made up of HIV care providers and professionals and the other made up of people infected with HIV who had started HAART within the last year. Each focus group met once, for approximately 2 hours, to determine what modifications would best adapt the CAP-IT program to HIV-infected people first starting HAART.
The second stage consisted of a randomized trial comparing the modified CAP-IT program to standard of care. Participation in this stage lasted for 72 weeks. Participants were randomly assigned to receive either standard care or the modified CAP-IT program in addition to standard care. The CAP-IT program involved two steps. The first was an assessment of factors relating to adherence, and the second was development of an individualized plan to address the deficits found.
Study visits were completed at entry, at Weeks 4 and 12, and then every 12 weeks for approximately 72 weeks. Assessments for the study included a questionnaire about health attitudes, a physical exam, counting of pills, and answering questions about taking medications.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 172 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections is the lead sponsor of 70 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Stage 1
HIV infected Individuals on Highly Active Antiretroviral Therapy (HAART):
Health Care Providers and Professionals:
Stage 2:
Exclusion Criteria:
Stage 1
HIV-1 Infected Individuals on HAART:
Health Care Providers and Professionals:
Stage 2:
Participants received the modified CAP-IT adherence intervention in addition to standard care. Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)
Behavioral: CAP-IT
Participants received standard care.
Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)
Also known as: Client adherence profiling and intervention tailoring
Mean Self-reported Adherence Score (%) Over a One-month Recall
The adherence self-report questionnaire captured adherence at an Antiretroviral Therapy (ART) regimen over a one-month recall (0-100): 0 means none of anti-HIV medications were taken, 100 means every single dose of anti-HIV medications were taken. The primary endpoint evaluated for each participant was the average self-reported adherence over a one-month recall across each of their study visit week 4, 12, 24, 36, and 48: missing values were ignored. Note: This was a change to the primary endpoint as described in the study protocol. This was due to an update to ACTG Case Report Form (CRF) that captured self-report adherence. Since the data captured on this form captured adherence over a longer timeframe and allowed for more variability in response, it was anticipated this endpoint would provide greater power to assess treatment differences.
Time frame: At weeks 4, 12, 24, 36, and 48
Mean Self-reported Adherence Score Over a One-month Recall
The mean of participant's average self-reported adherence score over a one-month recall across visit week 4, 12, 24, 36, 48, 60, and 72; missing values were ignored.
Time frame: Weeks 4, 12, 24, 36, 48, 60, and 72
Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48
The Kaplan-Meier estimate of the cumulative probability of initial antiretroviral (ARV) treatment regimen for any reason by week 48. Time to ARV treatment regimen change was defined as first time to change in the drug class of participant's ART regimen for any reason from study entry. Participants completing the study without a change in the drug class of their ART regimen were censored at their last visit.
Time frame: From study entry to week 48
Virologic Suppression
Virologic suppression was defined as HIV-1 RNA \<=200 copies/mL at week 24, 48, and 72. The results obtained within +/- 12 weeks of 24, 48, and 72 weeks were included. If there were multiple HIV-1 RNA measurement within the specified window, the HIV-1 RNA result closest to the center of the window was selected.
Time frame: At week 24, 48, 72
Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score
The GSES is a 10-item scale designed to assess optimistic self-beliefs used to cope with a variety of demands in life. The scale was designed to assess self efficacy, i.e., the belief that one's actions are responsible for successful outcomes. The scaled score for each question ranges from 1 to 4. Higher scores indicate participant's stronger belief in self-efficacy. The GSES score was sum of all responses. The range was from 0 to 40 scores: any unfinished question got a score of zero.
Time frame: At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72
Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)
The Kaplan-Meier estimate of the cumulative probability of experiencing a grade 3 or 4 adverse event by week 72. New Grade 3 or 4 signs, symptoms were identified by MedDRA preferred term. Events were included regardless of participant status on ART. If a participant had multiple reports of the same event, only the event reported at the highest grade were included. Time was measured from the study entry until the date of the first new grade 3 or 4 adverse event. Participants lost to follow-up prior to reaching an adverse event endpoint or not documented to have reached an adverse event endpoint at the end of the study had their endpoint censored at the date of their last visit.
Time frame: From study entry to week 72
| Milestone | CAP-IT | Standard Care |
|---|---|---|
| Started | 86 | 86 |
| Completed | 72 | 73 |
| Not completed | 14 | 13 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 14 | 12 |
The adherence self-report questionnaire captured adherence at an Antiretroviral Therapy (ART) regimen over a one-month recall (0-100): 0 means none of anti-HIV medications were taken, 100 means every single dose of anti-HIV medications were taken. The primary endpoint evaluated for each participant was the average self-reported adherence over a one-month recall across each of their study visit week 4, 12, 24, 36, and 48: missing values were ignored. Note: This was a change to the primary endpoint as described in the study protocol. This was due to an update to ACTG Case Report Form (CRF) that captured self-report adherence. Since the data captured on this form captured adherence over a longer timeframe and allowed for more variability in response, it was anticipated this endpoint would provide greater power to assess treatment differences.
| percentage of adherence score | CAP-IT | Standard Care |
|---|---|---|
| Mean Self-reported Adherence Score (%) Over a One-month Recall | 97.5 (93.4 to 100.0) | 98.2 (94.0 to 99.8) |
The mean of participant's average self-reported adherence score over a one-month recall across visit week 4, 12, 24, 36, 48, 60, and 72; missing values were ignored.
| percentage of adherence score | CAP-IT | Standard Care |
|---|---|---|
| Mean Self-reported Adherence Score Over a One-month Recall | 97.2 (92.9 to 99.4) | 97.8 (93.4 to 99.7) |
The Kaplan-Meier estimate of the cumulative probability of initial antiretroviral (ARV) treatment regimen for any reason by week 48. Time to ARV treatment regimen change was defined as first time to change in the drug class of participant's ART regimen for any reason from study entry. Participants completing the study without a change in the drug class of their ART regimen were censored at their last visit.
| cumulative probability per 100 persons | CAP-IT | Standard Care |
|---|---|---|
| Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48 | 17 (9 to 25) | 19 (11 to 28) |
Virologic suppression was defined as HIV-1 RNA \<=200 copies/mL at week 24, 48, and 72. The results obtained within +/- 12 weeks of 24, 48, and 72 weeks were included. If there were multiple HIV-1 RNA measurement within the specified window, the HIV-1 RNA result closest to the center of the window was selected.
| percentage of participants | CAP-IT | Standard Care |
|---|---|---|
| Week 24 (nCAP-IT=80, nSOC=79) | 94 (88 to 99) | 86 (78 to 94) |
| Week 48 (nCAP-IT=77, nSOC=73) | 95 (90 to 100) | 85 (77 to 93) |
| Week 72 (nCAP-IT=64, nSOC=66) | 88 (79 to 96) | 88 (80 to 96) |
The GSES is a 10-item scale designed to assess optimistic self-beliefs used to cope with a variety of demands in life. The scale was designed to assess self efficacy, i.e., the belief that one's actions are responsible for successful outcomes. The scaled score for each question ranges from 1 to 4. Higher scores indicate participant's stronger belief in self-efficacy. The GSES score was sum of all responses. The range was from 0 to 40 scores: any unfinished question got a score of zero.
| scores on a scale | CAP-IT | Standard Care |
|---|---|---|
| Week 0 (nCAP-IT=86, nSOC=86) | 36 (31 to 39) | 36 (32 to 38) |
| Week 4 (nCAP-IT=84, nSOC=86) | 37 (33 to 38) | 36 (31 to 39) |
| Week 12 (nCAP-IT=81, nSOC=77) | 36 (33 to 38) | 36 (32 to 39) |
| Week 24 (nCAP-IT=81, nSOC=82) | 36 (32 to 39) | 37 (34 to 39) |
| Week 36 (nCAP-IT=81, nSOC=79) | 37 (33 to 39) | 37 (33 to 39) |
| Week 48 (nCAP-IT=75, nSOC=77) | 37 (34 to 40) | 38 (33 to 40) |
| Week 60 (nCAP-IT=73, nSOC=73) | 37 (34 to 39) | 36 (33 to 39) |
| Week 72 (nCAP-IT=71, nSOC=72) | 37 (31 to 40) | 38 (33 to 40) |
The Kaplan-Meier estimate of the cumulative probability of experiencing a grade 3 or 4 adverse event by week 72. New Grade 3 or 4 signs, symptoms were identified by MedDRA preferred term. Events were included regardless of participant status on ART. If a participant had multiple reports of the same event, only the event reported at the highest grade were included. Time was measured from the study entry until the date of the first new grade 3 or 4 adverse event. Participants lost to follow-up prior to reaching an adverse event endpoint or not documented to have reached an adverse event endpoint at the end of the study had their endpoint censored at the date of their last visit.
| cumulative probability per 100 persons | CAP-IT | Standard Care |
|---|---|---|
| Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs) | 6 (3 to 14) | 2 (1 to 9) |
Collected over From treatment dispensation until off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAP-IT | — | 0/86 (0%) | 44/86 (51.2%) |
| Standard Care | — | 0/86 (0%) | 38/86 (44.2%) |
| Event | CAP-IT | Standard Care |
|---|---|---|
| Drug hypersensitivityImmune system disorders | 30/86 | 23/86 |
| AnaemiaBlood and lymphatic system disorders | 9/86 | 6/86 |
| DepressionPsychiatric disorders | 9/86 | 2/86 |
| DiarrhoeaGastrointestinal disorders | 8/86 | 4/86 |
| Anogenital wartsNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/86 | 8/86 |
| NauseaGastrointestinal disorders | 7/86 | 4/86 |
| NasopharyngitisInfections and infestations | 7/86 | 5/86 |
| DizzinessNervous system disorders | 7/86 | 4/86 |
| HeadacheNervous system disorders | 7/86 | 3/86 |
| HypertransaminasaemiaHepatobiliary disorders | 4/86 | 6/86 |
Intention to treat: All eligible participants were included in the baseline characteristics.
| Age, Continuous(years) | CAP-IT | Standard Care | Total |
|---|---|---|---|
| Mean | 31 ± 8 | 32 ± 10 | 31 ± 9 |
| Age, Customized(participants) | CAP-IT | Standard Care | Total |
|---|---|---|---|
| 18-29 years | 48 | 43 | 91 |
| 30-39 years | 25 | 23 | 48 |
| 40-49 years | 10 | 14 | 24 |
| 50+ years | 3 | 6 | 9 |
| Sex: Female, Male(Participants) | CAP-IT | Standard Care | Total |
|---|---|---|---|
| Female | 1 | 5 | 6 |
| Male | 85 | 81 | 166 |
| Race/Ethnicity, Customized(participants) | CAP-IT | Standard Care | Total |
|---|---|---|---|
| White Non-Hispanic | 7 | 16 | 23 |
| Black Non-Hispanic | 4 | 1 | 5 |
| Hispanic (Regardless of Race) | 73 | 62 | 135 |
| Asian, Pacific Islander | 0 | 3 | 3 |
| More than Once Race | 1 | 1 | 2 |
| Missing | 1 | 3 | 4 |
| Region of Enrollment(participants) | CAP-IT | Standard Care | Total |
|---|---|---|---|
| United States | 26 | 26 | 52 |
| Peru | 60 | 60 | 120 |
| Regimen complexity(participants) | CAP-IT | Standard Care | Total |
|---|---|---|---|
| QD | 25 | 25 | 50 |
| BID or TID | 61 | 61 | 122 |
| HIV-1 RNA(log10 copies/mL) | CAP-IT | Standard Care | Total |
|---|---|---|---|
| Mean | 4.9 ± 0.8 | 5.0 ± 0.7 | 5.0 ± 0.7 |
| CD4+ T-cell count(cells/mm^3) | CAP-IT | Standard Care | Total |
|---|---|---|---|
| Mean | 318 ± 178 | 313 ± 213 | 315 ± 195 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections