Supporting Sustained HIV Treatment Adherence After Initiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 3
- 主要终点
- HIV viral suppression at 24 months
研究概览
简要总结
The investigators will implement a 24-month fractional factorial design study (Aim 1). The investigators will recruit 510 patients initiating antiretroviral therapy (ART) at three City of Cape Town ART clinics. Each patient will have adherence monitored using the Wisepill® electronic adherence monitoring device (EAM). After eligibility has been confirmed, each participant will be randomized to one of 16 experimental conditions. Each condition includes a unique combination of five adherence intervention components. Three of these components focus on identifying individuals with poor adherence, with increasing degrees of sophistication, with immediate linkage to adherence support. Two components focus on supporting good adherence. They both supplement the existing adherence support program delivered at the study clinics operated by City of Cape Town (standard of care component). Based on Self-Determination Theory, the investigators postulate these intervention components will: 1) enhance feelings of autonomy support, social support, and knowledge; 2) improve motivation and self-competence; and 3) increase ART retention, adherence, and viral suppression. A subset of the participants, as well as clinic staff, will be invited to in-depth interviews to explore mediating factors (Aim 1) and the implementation process (Aim 2); and the data collected in Aims 1 and 2 will be used to explore cost effectiveness (Aim 3).
详细描述
The study's primary research goal is to identify the optimal combination of evidence-based and scalable HIV interventions for low-resource, high-burden settings. The investigators propose to 1) test the relative contribution of five promising intervention components; 2) collect cost and other implementation data; and 3) create a multi-component intervention package to optimize cost-effectiveness and implementation success. Of the five components, three are methods of non-adherence detection plus patient outreach; two are adherence support methods that can be integrated into Cape Town healthcare systems. These will not overcome all challenges that ART patients experience (e.g., structural barriers such as food insecurity) but they represent scalable, feasible, acceptable, and effective options. Notably, they are all behavioral approaches grounded in the experience and priorities of local health officials with whom the investigators have worked to identify scaleable interventions. While the study will be in Cape Town, it is broadly adaptable to other resource-limited settings.
The gold standard for testing interventions is the randomized controlled trial (RCT), which minimizes bias when testing cause and effect of a new exposure. When testing an intervention with more than one element, however, untangling the effect of individual elements is impossible. Indeed, data on the performance of individual components and their interactions-critical for developing and refining the components of a packaged intervention-is lost in an RCT. Notably, clinical care typically relies on packages of services, not single interventions, and packaged interventions are recommended for ART support. An effective way to test a multi-component intervention is to use the novel Multiphase Optimization STrategy (MOST), an engineering-inspired method for identifying the most efficacious combination of components in a packaged intervention, thus allowing researchers to drop inactive or weakly-performing components and construct an optimized package based on effect, cost, and other features. Once the optimized multi-component intervention is chosen, an RCT or quasi-experiment can follow to determine whether the optimized package yields superior outcomes compared to existing standards. MOST encompasses three phases: 1) preparation; 2) optimization; and 3) evaluation, often in an RCT. In this project, we have completed preparation, including a pilot study in Cape Town. SUSTAIN will comprise the middle optimization phase. The evaluation phase will be the focus of a future study.
The specific aims are:
Aim 1. Employ a highly efficient fractional factorial design to determine the effects of five intervention components on the primary outcome (HIV viral suppression) and secondary outcomes (ART adherence measured by EAM, ART retention per clinic records, days of unsuppressed virus, time to nonadherence detection, and time to linkage to support). The investigators will explore effect mechanisms quantitatively and qualitatively.
Aim 2. Evaluate the intervention components to address implementation, service, and client outcomes according to the Proctor framework. Data collection will involve tracking of intervention component use, time and motion studies, and quantitative surveys and qualitative interviews with participants and staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main study:
- •Adults (≥18 years) and adolescents 16-17 years.
- •HIV-positive and attending a local City of Cape Town (COCT) clinic to commence ART.
- •Able to provide full informed consent, with a written signature. For those who are illiterate, a witness will be present throughout the process and will sign the form, while the participant will add their right thumb print. For those who are aged 16-17 years, informed written assent will be obtained, and the adolescent must have a parent or guardian who can provide full informed consent (see **below for how parent/guardian is defined for this purpose).
- •Access to a working cellphone and willingness to receive study-related messaging on that phone.
- •Willingness to comply with study procedures, including providing regular updates of contact details /locator information, and use a EAM device for the duration of participation.
- •Other Inclusion Criteria:
- •Aim 1: In-depth interviews (IDIs) with subset of trial subjects at baseline and months 12 and
- •Participation in the main trial.
- •Self-reported prior experience with substance use, depression, gender inequity, stigma, or transport/clinic issues.
- •Aim 2: Questionnaires and IDIs with staff members at study clinics (three total clinics).
- •Adults (≥18 years)
- •Staff at study clinics, providing HIV care and/or treatment.
- •Aim 2: Focus group discussion (FGD) with City of Cape Town officials.
- •Adults (≥18 years)
- •Staff at City of Cape Town.
排除标准
- •Main study:
- •Clinical conditions as assessed by the COCT clinic clinicians at first visit e.g. renal disease, which preclude the use of a single tablet regimen (with the exception of those on tuberculosis (TB) treatment who are required to take an extra dose of dolutegravir daily).
- •Planning to leave Cape Town permanently within the next 24 months.
- •Being perinatally infected with HIV. Being infected from birth typically means a set of experiences and complications at a young age that require unique and special attention.
- •If an adolescent, taking their ART medication as a syrup, as they are required to use the electronic adherence monitor (Wisepill device), which is only suitable for tablets.
- •Other Inclusion Criteria:
- •Aim 1: IDIs with trial subjects.
- •Aim 2: Questionnaires and IDIs with staff members at clinics. • None.
- •Aim 2: FGD with City of Cape Town officials.
研究组 & 干预措施
Condition 7
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: M3/EAM: Immediate outreach to subject after EAM-identified missed doses (Behavioral)
Condition 1
Includes 1 intervention:
S2/Peer: Enhanced peer group support.
干预措施: S2/Peer: Enhanced peer group support (Behavioral)
Condition 2
Includes 1 intervention:
S1/Text: Weekly check-in text messages.
干预措施: S1/Text: Weekly check-in texts (Behavioral)
Condition 4
Includes 3 interventions:
M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: M3/EAM: Immediate outreach to subject after EAM-identified missed doses (Behavioral)
Condition 3
Includes 1 intervention:
M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient.
干预措施: M3/EAM: Immediate outreach to subject after EAM-identified missed doses (Behavioral)
Condition 4
Includes 3 interventions:
M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: S1/Text: Weekly check-in texts (Behavioral)
Condition 4
Includes 3 interventions:
M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: S2/Peer: Enhanced peer group support (Behavioral)
Condition 5
Includes 1 intervention:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient.
干预措施: M2/PRM: Immediate outreach to subject after a missed pharmacy refill (Behavioral)
Condition 6
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: M2/PRM: Immediate outreach to subject after a missed pharmacy refill (Behavioral)
Condition 6
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: S1/Text: Weekly check-in texts (Behavioral)
Condition 6
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: S2/Peer: Enhanced peer group support (Behavioral)
Condition 7
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: M2/PRM: Immediate outreach to subject after a missed pharmacy refill (Behavioral)
Condition 7
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: S2/Peer: Enhanced peer group support (Behavioral)
Condition 8
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: M2/PRM: Immediate outreach to subject after a missed pharmacy refill (Behavioral)
Condition 8
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: M3/EAM: Immediate outreach to subject after EAM-identified missed doses (Behavioral)
Condition 8
Includes 3 interventions:
M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: S1/Text: Weekly check-in texts (Behavioral)
Condition 14
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: M2/PRM: Immediate outreach to subject after a missed pharmacy refill (Behavioral)
Condition 9
Includes 1 intervention:
M1/OTR: Outreach (OTR) to patient due to unsuppressed VL test result.
干预措施: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result (Behavioral)
Condition 10
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result (Behavioral)
Condition 10
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: S1/Text: Weekly check-in texts (Behavioral)
Condition 10
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: S2/Peer: Enhanced peer group support (Behavioral)
Condition 11
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result (Behavioral)
Condition 11
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: M3/EAM: Immediate outreach to subject after EAM-identified missed doses (Behavioral)
Condition 11
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: S2/Peer: Enhanced peer group support (Behavioral)
Condition 12
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result (Behavioral)
Condition 12
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: M3/EAM: Immediate outreach to subject after EAM-identified missed doses (Behavioral)
Condition 12
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: S1/Text: Weekly check-in texts (Behavioral)
Condition 13
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result (Behavioral)
Condition 13
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: M2/PRM: Immediate outreach to subject after a missed pharmacy refill (Behavioral)
Condition 13
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S2/Peer: Enhanced peer group support.
干预措施: S2/Peer: Enhanced peer group support (Behavioral)
Condition 14
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result (Behavioral)
Condition 14
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; S1/Text: Weekly check-in text messages.
干预措施: S1/Text: Weekly check-in texts (Behavioral)
Condition 15
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient.
干预措施: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result (Behavioral)
Condition 15
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient.
干预措施: M2/PRM: Immediate outreach to subject after a missed pharmacy refill (Behavioral)
Condition 15
Includes 3 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient.
干预措施: M3/EAM: Immediate outreach to subject after EAM-identified missed doses (Behavioral)
Condition 16
Includes 5 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: M2/PRM: Immediate outreach to subject after a missed pharmacy refill (Behavioral)
Condition 16
Includes 5 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result (Behavioral)
Condition 16
Includes 5 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: M3/EAM: Immediate outreach to subject after EAM-identified missed doses (Behavioral)
Condition 16
Includes 5 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: S1/Text: Weekly check-in texts (Behavioral)
Condition 16
Includes 5 interventions:
M1/OTR: Outreach to patient due to unsuppressed VL test result; M2/PRM: Pharmacy refill monitoring (PRM) + outreach to the patient; M3/EAM: Electronic adherence monitoring (EAM) + outreach to the patient; S1/Text: Weekly check-in text messages; S2/Peer: Enhanced peer group support.
干预措施: S2/Peer: Enhanced peer group support (Behavioral)
结局指标
主要结局
HIV viral suppression at 24 months
时间窗: 24 months
This outcome will measure the effect of the interventions on HIV viral suppression from enrollment to the end of study participation. HIV viral suppression will be defined as % plasma viral load (VL) \<50 copies/mL (dichotomous).
次要结局
- Mean adherence from baseline through 24 months(baseline through 24 months)
- Change in HIV viral load between baseline and 24 months(baseline, 24 months)
- Days of unsuppressed virus between baseline and 24 months(baseline, 24 months)
- Achievement of ≥ 90% adherence in month 24(month 24)
- HIV viral suppression at 12 months(12 months)
- Change in HIV viral load between baseline and 12 months(baseline, 12 months)