Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial.

OBJECTIVE: Evaluate a computerized intervention supporting antiretroviral therapy (ART) adherence and HIV transmission prevention. DESIGN: Longitudinal randomized controlled trial. SETTINGS: An academic HIV clinic and a community-based organization in Seattle. SUBJECTS: In a total of 240 HIV-positive adults on ART, 209 completed 9-month follow-up (87% retention). INTERVENTION: Randomization to computerized counseling or assessment only, 4 sessions over 9 months. MAIN OUTCOME MEASURES: HIV-1 viral suppression, and self-reported ART adherence and transmission risks, compared using generalized estimating equations. RESULTS: Overall, intervention participants had reduced viral load: mean 0.17 log10 decline, versus 0.13 increase in controls, P = 0.053, and significant difference in ART adherence baseline to 9 months (P = 0.046). Their sexual transmission risk behaviors decreased (odds ratio = 0.55, P = 0.020), a reduction not seen among controls (odds ratio = 1.1, P = 0.664), and a significant difference in change (P = 0.040). Intervention effect was driven by those most in need; among those with detectable virus at baseline (>30 copies/mL, n = 89), intervention effect was mean 0.60 log10 viral load decline versus 0.15 increase in controls, P = 0.034. ART adherence at the final follow-up was 13 points higher among intervention participants versus controls, P = 0.038. CONCLUSIONS: Computerized counseling is promising for integrated ART adherence and safer sex, especially for individuals with problems in these areas. This is the first intervention to report improved ART adherence, viral suppression, and reduced secondary sexual transmission risk behavior.

Peer support and pager messaging to promote antiretroviral modifying therapy in Seattle: a randomized controlled trial.

OBJECTIVE: To determine the relative efficacy of peer support and pager messaging strategies versus usual care to improve medication adherence and clinical outcomes among HIV-positive outpatients initiating or switching to a new highly active antiretroviral therapy regimen. DESIGN: A 2 3 2 factorial randomized controlled trial of a 3-month intervention with computer-assisted self-interviews and blood draws administered at baseline, 3, 6, and 9 months. METHODS: HIV-positive patients at a public HIV specialty clinic in Seattle,WA (N = 224) were randomly assigned to peer support, pager messaging, both strategies, or usual care. The main outcomes were adherence according to self-report and electronic drug monitoring, CD4 count, and HIV-1 RNA viral load. RESULTS: Intent-to-treat analyses suggested the peer intervention was associated with greater self-reported adherence at immediate postintervention. However, these effects were not maintained at follow-up assessment; nor were there significant differences in biological outcomes. The pager intervention, on the other hand, was not associated with greater adherence but was associated with improved biological outcomes at postintervention that were sustained at follow-up. CONCLUSIONS: Analyses indicate the potential efficacy of peer support and pager messaging to promote antiretroviral adherence and biological outcomes, respectively. More potent strategies still are needed.

Self-report measures of antiretroviral therapy adherence: A review with recommendations for HIV research and clinical management.

A review of 77 studies employing self-report measures of antiretroviral adherence published 1/1996 through 8/2004 revealed great variety in adherence assessment item content, format, and response options. Recall periods ranged from 2 to 365 days (mode = 7 days). The most common cutoff for optimal adherence was 100% (21/48 studies, or 44%). In 27 of 34 recall periods (79%), self-reported adherence was associated with adherence as assessed with other indirect measures. Data from 57 of 67 recall periods (84%) indicated self-reported adherence was significantly associated with HIV-1 RNA viral load; in 16 of 26 (62%), it was associated with CD4 count. Clearly, the field would benefit from item standardization and a priori definitions and operationalizations of adherence. We conclude that even brief self-report measures of antiretroviral adherence can be robust, and recommend items and strategies for HIV research and clinical management.

A longitudinal evaluation of a social support model of medication adherence among HIV-positive men and women on antiretroviral therapy.

Nonadherence in the management of chronic illness is a pervasive clinical challenge. Although researchers have identified multiple correlates of adherence, the field remains relatively atheoretical. The authors propose a cognitive-affective model of medication adherence based on social support theory and research. Structural equation modeling of longitudinal survey data from 136 mainly African American and Puerto Rican men and women with HIV/AIDS provided preliminary support for a modified model. Specifically, baseline data indicated social support was associated with less negative affect and greater spirituality, which, in turn, were associated with self-efficacy to adhere. Self-efficacy to adhere at baseline predicted self-reported adherence at 3 months, which predicted chart-extracted viral load at 6 months. The findings have relevance for theory building, intervention development, and clinical practice.

A two-way messaging system to enhance antiretroviral adherence.

Failure to adhere to complex antiretroviral regimens can lead to resistance and treatment failure among HIV-positive persons. In this study of the feasibility of an automated two-way messaging system to improve adherence, participants received multiple short daily messages designed to remind, educate, encourage adherence, and solicit responses concerning side effects and self-reported adherence. Twenty-five participants remained in the study for a median of 208 days, receiving 17,440 messages and replying to 14,677 (84%). Participants reported missing one or more doses on 36% of 743 queries and reported medication side effects on 26% of 729 queries. Participants expressed high satisfaction with the messaging system and reported that it helped with medication adherence. The study suggests that it is feasible to use an automated wireless two-way messaging system to communicate with HIV-positive patients over an extended period of time.

Antiretroviral adherence interventions: a review of current literature and ongoing studies.

Adherence has proven to be Achilles' heel of antiretroviral therapy. To achieve the nearly perfect adherence apparently necessary for optimal effects, individuals often require assistance. In this review, we examine antiretroviral therapy adherence intervention studies and reviews published through January 2003 as well as abstracts of ongoing National Institutes of Health-funded research projects aimed at enhancing antiretroviral therapy adherence. The 21 published studies we located utilized 4 intervention strategies: cognitive-behavioral, behavioral, directly observed therapy, and affective. Most of these were pilot or feasibility studies. However, the 4 randomized controlled trials conducted with adequate methologic rigor suggest some promising yet preliminary effects of a pharmacist-led individualized intervention, a cognitive-behavioral educational intervention based on self-efficacy theory, and cue-dose training when combined with monetary reinforcement. The 39 ongoing federally funded studies offer superior methodologic sophistication and include some innovative strategies, such as the use of handheld devices, two-way pagers, and alarmed medication vials, along with enhancement of social and emotional support.

Mediators of social support and antiretroviral adherence among an indigent population in New York City.

Survey interviews were conducted with a random sample of 50 primarily indigent, African American and Puerto Rican men and women at an outpatient human immunodeficiency virus (HIV) clinic in the Bronx, New York. Analyses revealed a generally high rate of adherence according to self-report data (i.e., on average, participants reported taking 85% of their medications over the last 3 days). However, adherence to the correct number of pills, dosing schedules, and special instructions was more problematic. No sociodemographic or substance use indicators were associated with adherence. Compared to men, women reported higher scores on the Crowne-Marlowe Social Desirability Scale, which were positively correlated with self-reported adherence. "Forgot" (50%) and "felt worse" (46%) were the most common reasons for missed doses. Mediation analyses provided partial support for our proposed model of social support and adherence. Specifically, regression analyses controlling for social desirability indicated that need for social support was positively correlated with acknowledged nonadherence and that this relationship was mediated by self-efficacy and depressive symptomatology.