Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India: a Randomized Factorial Trial With a Randomized Adaptive Component for Those Experiencing Early Treatment Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-1 randomization
研究概览
简要总结
The goal of this study is to improve HIV care outcomes for people who inject drugs (PWID) in India. The study will implement a two-phase trial to evaluate whether HIV treatment outcomes (HIV viral suppression) in HIV infected PWID can be improved with three different interventions: i) by offering a faster treatment start time (same-day antiretroviral therapy [ART] initiation vs. standard), ii) by provided community-based HIV care in PWID-focused centers (vs. centralized government-based HIV care) and, iii) providing an enhanced adherence support to participants who experience treatment failure at six months (vs. routine adherence support). The investigators hypothesize that faster access to ART and HIV treatment in PWID-focused community sites will lead to higher levels of initiation and retention to ART compared with standard care; and use of enhanced navigation and psychosocial support to patients who experience treatment failure at six months will lead to improved viral suppression compared with routine adherence support.
详细描述
People who inject drugs (PWID) are at high risk for HIV infection and experience worse antiretroviral therapy (ART) outcomes than other key populations, particularly in low and middle income countries (LMIC). India has the largest number of opioid users in the world, and new injection drug epidemics have emerged in the North and Central regions of the country.
In phase 1, the investigators will evaluate two structural interventions to improve treatment outcomes among HIV-positive PWID in India. First, same-day ART (initiating ART on the day of HIV diagnosis/confirmation rather than waiting until standard evaluations are completed in an HIV clinic), was found to increase viral suppression rates in African studies with generalized HIV epidemics, but has not been evaluated in PWID. The second intervention is community-based HIV care. At present, all publicly-financed HIV treatment is provided at designated government ART centers. In prior work, the investigators found that PWID-centric integrated care centers (ICCs) were effective at engaging the population and increasing HIV testing uptake and were rated favorably by clients in anonymous surveys. ICCs linked HIV-positive PWID to government clinics, but were not equipped to provide primary HIV care. However, ICCs can be scaled-up to provide HIV treatment on-site and the investigators hypothesize this will improve initiation and retention to ART among PWID. The investigators will use a randomized factorial design to determine the individual and joint effects of same-day ART initiation and community-based HIV care. The primary outcome of the phase-1 trial is viral suppression at 6 months, with longer term follow-up to 18 months.
In phase 2, the investigators will evaluate a psychosocial/navigation intervention (enhanced adherence support) among participants who experience treatment failure during the first trial phase, defined as non-suppressed HIV RNA at the 6-month visit. These participants will be randomly assigned (in a second randomization) to enhanced adherence support or routine adherence support. The primary outcome of phase-2 will be viral suppression 6 months following the second randomization (12 months from enrollment in phase-1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PHASE 1 Inclusion Criteria:
- •18 years of age or older
- •Reports injection drug use in prior 24 months
- •Documented HIV positive
- •Antiretroviral therapy naïve
- •HIV RNA 1,000 c/mL or higher
- •If previously linked to HIV care, able and willing to provide govt. ART book for documentation of care received.
排除标准
- •Pregnant (if female)
- •Does not speak English, Hindi, or local language
- •Plans to migrate in next 12 months
- •Not competent to participate in the study or provide written informed consent.
- •PHASE 2 Inclusion Criteria:
- •Participants who experience treatment failure at 6 months (HIV RNA>1000c/mL)
- •PHASE 2 Exclusion Criteria:
- •Participants who do not experience treatment failure at 6 months
研究组 & 干预措施
Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support
Participants randomized to Arm 4 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Standard ART initiation [usual care] (Behavioral)
Arm 1: standard ART initiation + government-based HIV care + routine adherence support
Participants randomized to Arm 1 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Standard ART initiation [usual care] (Behavioral)
Arm 1: standard ART initiation + government-based HIV care + routine adherence support
Participants randomized to Arm 1 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Government-based HIV care [usual care] (Other)
Arm 1: standard ART initiation + government-based HIV care + routine adherence support
Participants randomized to Arm 1 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Routine adherence support [usual care] (Behavioral)
Arm 2: same-day ART + government-based HIV care + routine adherence support
Participants randomized to Arm 2 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Same-day ART initiation [experimental] (Behavioral)
Arm 2: same-day ART + government-based HIV care + routine adherence support
Participants randomized to Arm 2 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Government-based HIV care [usual care] (Other)
Arm 2: same-day ART + government-based HIV care + routine adherence support
Participants randomized to Arm 2 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Routine adherence support [usual care] (Behavioral)
Arm 3: standard ART initiation + community-based HIV care + routine adherence support
Participants randomized to Arm 3 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Standard ART initiation [usual care] (Behavioral)
Arm 3: standard ART initiation + community-based HIV care + routine adherence support
Participants randomized to Arm 3 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Community-based HIV care [experimental] (Other)
Arm 3: standard ART initiation + community-based HIV care + routine adherence support
Participants randomized to Arm 3 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Routine adherence support [usual care] (Behavioral)
Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support
Participants randomized to Arm 4 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Government-based HIV care [usual care] (Other)
Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support
Participants randomized to Arm 4 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Enhanced adherence support [experimental] (Behavioral)
Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support
Participants randomized to Arm 5 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Same-day ART initiation [experimental] (Behavioral)
Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support
Participants randomized to Arm 5 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Community-based HIV care [experimental] (Other)
Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support
Participants randomized to Arm 5 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive routine adherence support should they experience treatment failure at 6 months [usual care].
干预措施: Routine adherence support [usual care] (Behavioral)
Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support
Participants randomized to Arm 6 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Same-day ART initiation [experimental] (Behavioral)
Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support
Participants randomized to Arm 6 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Government-based HIV care [usual care] (Other)
Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support
Participants randomized to Arm 6 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a government HIV clinic [usual care], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Enhanced adherence support [experimental] (Behavioral)
Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support
Participants randomized to Arm 7 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Standard ART initiation [usual care] (Behavioral)
Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support
Participants randomized to Arm 7 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Community-based HIV care [experimental] (Other)
Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support
Participants randomized to Arm 7 will i) initiate ART on a standard timeline [usual care], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Enhanced adherence support [experimental] (Behavioral)
Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support
Participants randomized to Arm 8 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Same-day ART initiation [experimental] (Behavioral)
Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support
Participants randomized to Arm 8 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Community-based HIV care [experimental] (Other)
Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support
Participants randomized to Arm 8 will i) initiate ART on the day of enrollment [experimental], ii) receive ongoing care in a PWID-focused community-based site [experimental], and iii) receive enhanced adherence support should they experience treatment failure at 6 months [experimental].
干预措施: Enhanced adherence support [experimental] (Behavioral)
结局指标
主要结局
Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-1 randomization
时间窗: Measured at 6 months following phase-1 randomization
HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL
Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-2 randomization
时间窗: Measured at 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL
次要结局
- Percentage of participants randomized in phase-1 with viral suppression (HIV RNA <1000 c/mL) at non-primary time points (i.e., 3, 12, and 18 months).(Measured at 3, 12, and 18 months after phase-1 randomization)
- Percentage of participants randomized in phase-2 with viral suppression (HIV RNA <1000 c/mL) at non-primary time point (18 months).(Measured at 12 months following phase-2 randomization (corresponding to 18 months after phase-1 randomization))
- All-cause mortality rate(Measured up to 21 months)
- Percentage of participants who link to ART at a clinic by 3- or 6-months following randomization(Measured at 3 months and 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization))
- Percentage of participants adherent to ART measured by self-report(Measured at 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization))
- Percentage of participants adherent to ART measured by medication possession ratio (MPR)(Measured at 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization))