Durability of Adherence in Self-Management of HIV

NCT00991302 | Completed Results DMC

• 3 other identifiers: ACTG A52501U01AI06863610654
• Study Type: interventional
• Target: 172
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

HIV Infections

Keywords

Adherence; Behavioral Intervention; Antiretroviral Therapy; ART; Highly Active Antiretroviral Therapy; HAART; Treatment experienced

Outcome Measures

Primary Outcomes (1)

• 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.

  At weeks 4, 12, 24, 36, and 48

Secondary Outcomes (5)

• Mean Self-reported Adherence Score Over a One-month Recall

  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

  From study entry to week 48

• Virologic Suppression

  At week 24, 48, 72

• Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score

  At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72

• Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)

  From study entry to week 72

Study Arms (2)

CAP-IT

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Participants received standard care.

Interventions

CAP-IT BEHAVIORAL

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

CAP-IT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 1
• HIV infected Individuals on Highly Active Antiretroviral Therapy (HAART):
• HIV-1 infection
• Initiated HAART within 1 year prior to study entry and remained on HAART for at least 30 consecutive days
• Men and women who hade reached the legal age of majority in the country where they are being enrolled
• Ability and willingness to provide informed consent
• Willingness to discuss personal topics during an audio-taped group interview
• Willingness to protect the confidentiality of other focus group participants
• Health Care Providers and Professionals:
• Healthcare providers or professionals (e.g., medical doctors \[MDs\], nurse practitioner \[NPs\], physician assistants \[PAs\], adherence counselors) recruited from outside of the local clinical research site (CRS) whose patient population included a majority of HIV-1 seropositive patients and who had recent experience managing ART-naive individuals starting HAART
• Men and women who had reached the legal age of majority in the country where they are being enrolled
• Willingness to discuss personal topics during an audio-taped group interview
• Willingness to protect the confidentiality of other focus group participants and of the proceedings
• Stage 2:
• HIV-1 infection

You may not qualify if:

• Stage 1
• HIV-1 Infected Individuals on HAART:
• Failure to remain on HAART for at least 30 consecutive days
• Diminished cognitive capacity that, in the opinion of the screening CRS clinician, would interfere with study participation
• Participation in any prior focus group for study A5250
• Health Care Providers and Professionals:
• Health care providers and professionals who would be involved in administering standard of care (SOC) treatment and adherence counseling to Stage 2 participants randomized to the SOC arm or CRS investigators or health care providers and professionals directly involved in measuring adherence outcomes in Stage 2
• Participation in any prior focus group for study A5250
• Stage 2:
• Potential participants who were, in the judgment of the research team, unable to complete the protocol
• Potential participants who were starting a NNRTI-based regimen within 12 months after receiving single-dose NVP during pregnancy to prevent MTCT of HIV
• Potential participants who were partners or close contacts of participants enrolled in Stage 2
• Potential participants who were currently enrolled in an ACTG protocol utilizing or testing an adherence intervention

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Ucsd, Avrc Crs

San Diego, California, 92037, United States

Location

Barranco CRS (11301)

Lima, 18 PE, Peru

Location

Related Publications (2)

• Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.

  PMID: 17577653 BACKGROUND

• Wagner GJ, Kanouse DE, Golinelli D, Miller LG, Daar ES, Witt MD, Diamond C, Tilles JG, Kemper CA, Larsen R, Goicoechea M, Haubrich RH. Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578). AIDS. 2006 Jun 12;20(9):1295-302. doi: 10.1097/01.aids.0000232238.28415.d2.

  PMID: 16816559 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: ACTG Clinicaltrials.gov Coordinator
• Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

ACTGCT.Gov@s-3.com

(301) 628-3313

Study Officials

• Constance Benson, MD

  University of California, San Diego

  STUDY CHAIR

• Tari Gilbert, MSN

  University of California, San Diego

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 20, 2018
• Results First Posted: August 26, 2015

Record last verified: 2018-02

Locations

US (1); PE (1)