TABLE 3—
Ongoing Test and Treat Research Studies: January 2009–May 2012
| Study Name | Study Type | Pertinent Research Objectives and Findings | Timeframe |
| Population Effect of ART to Reduce HIV Transmission | Phase I: mixed methods study of feasibility and acceptability of comprehensive testing program in rural (Masaka, Uganda) and urban (Kabwe, Zambia) locations; pilot of immediate ART initiation to 100 newly diagnosed HIV patients | Examine uptake of test and treat, community engagement to enhance acceptability and human rights concerns, cost-effectiveness to inform design of cluster RCT; for pilot patients, examine adherence, viral load, CD4, OI, and drug resistance for 1 year after initiation; community HIV incidence | Phase I: 2010–2013 Phase II: 2013– |
| Phase II: cluster-randomized trial of impact of treatment of all HIV-infected individuals | |||
| Treatment as Prevention | Phase 0: feasibility of providing universal testing and universal ART in South Africa | Examine best approaches to universal testing and universal ART to inform the design of cluster RCT; examine impact of ART on population HIV incidence, ARV resistance, HIV morbidity, adherence, adverse events, and high-risk behaviors and determine origin of new infections; examine population effectiveness and sustainability | Phase I: 2009–2011 Phase II: 2011–2015 Phase II: 2015– |
| Phase I: cluster-randomized trial of impact of treatment of all HIV-infected individuals | |||
| Phase II: expansion phase | |||
| National Institute of Mental Health Project Accept (NCT00203749) | Phase III: randomized control trial of community mobilization, mobile testing, same-day results, and posttest support for HIV in sub-Saharan Africa and Thailand | Examine efficacy of Community-Based HIV Voluntary Counseling and Testing (CBVCT) intervention plus standard clinic-based VCT (SVCT) or SVCT alone; CBVCT more effective than is SVCT in increased detection of HIV infection, especially in regions with restricted access to clinic-based VCT and support services after testing | Study completed in August 2011 |
| Effectiveness of ART plus HIV Primary Care versus Primary Care Alone to Prevent Sexual Transmission of HIV-1 in Serodiscordant Couples (HPTN052) | Phase III: 2-arm, randomized control, multicenter trial of early ART in 1750 discordant couples in 8 countries | Measure impact of 2 treatment initiation thresholds; first arm initiated on enrollment, second arm initiated at CD4 ≤ 250 cells/mm3, on disease transmission, HIV progression, and ART toxicity; dramatic 96% reduction in HIV transmission in couples with early treatment announced in May 2011 | Deferred treatment arm discontinued May 2011; data collection on secondary endpoints will continue through 2013 |
| TLC-Plus: Feasibility of an Enhanced Test, Link to Care, Plus Treat Approach for HIV Prevention in US | Feasibility and effectiveness study of test and treat and strengthened linkage programs in United States (New York City and Washington, DC) | Examine impact of 4 components of community-focused enhanced test-and-treat strategy on prompt ART initiation, viral suppression, and high-risk behaviors | Enrollment began in 2010 and is ongoing; data collection to end 2013 or 2014 |
| Strategic Timing of Antiretroviral Treatment | Randomized control trial of 4000 HIV-positive persons in 23 countries, minimum follow up 3 y | Compare immediate ART to deferred ART (CD4 ≤ 350 cells/mm3) for each component of the primary composite endpoint: AIDS, non-AIDS, or death from any cause | 2009–2015; data collection will be complete 2015 |
| Seek and Treat to Optimally Prevent HIV and AIDS | Phase III: population-based study of expanded ART availability in British Columbia, Canada | Measure impact of ART expansion on population HIV incidence at 3–5 y; secondary outcomes include AIDS morbidity and mortality, CD4 counts, viral load, drug resistance, safety, and health care utilization | 2010–2013; data collection will be complete end of 2013 |
Note. ART = antiretroviral therapy; CD4 = cluster of differentiation 4; HPTN = HIV Prevention Trials Network; OI = opportunistic infection; RCT = randomized control trial; TLC = testing and linkage to care; VCT = voluntary counseling and testing.