Partner-Focused Adherence Intervention for Second-line Antiretroviral Therapy: A Multinational Randomized Trial (ACTG A5234).

TitlePartner-Focused Adherence Intervention for Second-line Antiretroviral Therapy: A Multinational Randomized Trial (ACTG A5234).
Publication TypeJournal Article
Year of Publication2015
AuthorsGross R, Zheng L, La Rosa A, Sun X, Rosenkranz SL, Cardoso SWagner, Ssali F, Camp R, Godfrey C, Cohn SE, Robbins GK, Chisada A, Wallis CL, Reynolds NR, Lu D, Safren SA, Hosey L, Severe P, Collier AC
JournalLancet HIV
Volume2
Issue1
Paginatione12-e19
Date Published2015 Jan 1
ISSN2352-3018
Abstract

BACKGROUND: Adherence is key to antiretroviral therapy (ART) success. Enhanced partner support may benefit patients with prior treatment failure.

METHODS: We conducted a 1:1 randomized trial of a partner-based modified directly observed therapy (mDOT) compared with standard of care (SOC) at 9 sites in 8 countries. Participants had failed a first-line regimen with HIV RNA >1000 copies/mL and a willing partner. Randomization was computer generated and balanced by site. Participants and site investigators were not masked to group assignment. ART included lopinavir/ritonavir (400/100 mg) twice daily and emtricitabine/tenofovir disoproxil fumarate (200/300 mg) once daily. Trained partners observed one ART dose daily ≥5 days/week for 24 weeks. Primary outcome was HIV RNA >400 copies/mL before or at week 48 and adherence measured with microelectronic monitors was a secondary outcome.

FINDINGS: We randomized 129 participants to mDOT and 128 to SOC, 130 (51%) males, 204 (79%) of African origin, 52 (20%) Latino, with median age 38 years. Partners were parents, 57 (22%), spouses 55 (21%), siblings 50 (19%), friends 41 (16%), and others 54 (21%). Primary outcome occurred in 26% (34/129) of mDOT and 18% (23/128) of SOC participants at week 48 (p=0.13). Median adherence was similar [Q1: 95% vs. 96% p=0.38, Q2: 91% vs. 94% p=0.40, Q3: 90% vs. 93% p=0.17, Q4: 90% vs. 93% p=0.36] in mDOT and SOC, respectively.

INTERPRETATION: This intervention had no effect on outcomes. Potential reasons include study visits maximizing adherence in both groups and control partners already providing sufficient support. Partner-based training with mDOT does not appear promising to enhance adherence. Intensive follow-up with clinic staff may be a viable strategy in this setting.

DOI10.1016/S2352-3018(14)00007-1
Alternate JournalLancet HIV
PubMed ID25664336
PubMed Central IDPMC4313760
Grant ListP30 AI045008 / AI / NIAID NIH HHS / United States
UL1 TR000077 / TR / NCATS NIH HHS / United States
UM1 AI068634 / AI / NIAID NIH HHS / United States
UM1 AI068636 / AI / NIAID NIH HHS / United States
UM1 AI069419 / AI / NIAID NIH HHS / United States
UM1 AI069456 / AI / NIAID NIH HHS / United States
UM1 AI069471 / AI / NIAID NIH HHS / United States
UM1 AI069534 / AI / NIAID NIH HHS / United States
UM1 AI106701 / AI / NIAID NIH HHS / United States