The Treatment Ambassador Program: A Pilot Intervention to Increase Treatment Initiation
The Treatment Ambassador Program: Pilot Testing a Peer-driven Intervention to Increase Treatment Initiation Among HIV-positive South Africans
研究概览
详细说明
Global HIV treatment initiatives have focused on increasing access to antiretroviral therapy (ART), with the goal of creating an "AIDS-free generation." There is growing evidence, however, that treatment availability alone is insufficient to stop the spread of the disease. Countries where HIV is hyperendemic, such as South Africa, will not achieve population-level reductions in HIV until incident infections have been dramatically reduced over a lifetime, and people living with HIV (PLWH) no longer wait to start treatment until they have symptoms of advanced AIDS. As South Africa expands ART eligibility to all people living with HIV, it remains unclear if promoting earlier ART initiation will lead to widespread uptake. These operational realities raise two fundamental questions: how will we close the gap from the 3.4 million PLWH currently on ART to treating the over seven million people who need care; and what does this portend for the future of Treatment as Prevention in South Africa? The investigators' prior research suggests that optimizing ART initiation for PLWH in South Africa will require an intervention to reduce individual barriers to starting ART, promote social support, and enhance linkages to the healthcare system. In the proposed study, the investigators will build upon our prior research to pilot test a socio-behavioral multi-component peer intervention, to ensure that South Africans living with HIV initiate and sustain treatment. Investigators will test this intervention through a pilot randomized-controlled trial. This multi-component intervention is designed to address barriers to ART initiation identified in prior qualitative research, framed through the Theory of Triadic Influence (TTI). TTI focuses upon three "streams of influence" that impact health behavior at the individual-, social-, and structural-levels. The intervention will be delivered by "Treatment Ambassadors," who are PLWH who will function in multiple capacities, and have received intensive training in motivational interviewing (MI), peer-support, and peer navigation. They will then provide the intervention in eight sessions over 8-14 weeks. The intervention will be individually tailored to address the three streams of influence on patient decision-making as follows: MI will address individual perceived risk and ambivalence in decision-making; peer-support will target interpersonal social factors; and patient navigation will promote ART initiation and counter structural barriers.
Investigators will enroll 90 participants (45 in each arm) with the goal of assessing feasibility and acceptability. Investigators enrolled 84 participants in total. The 90 participant mark was not met due to time constraints and our eligibility requirements. In addition, preliminary efficacy will be assessed through the following measures:
Primary Outcome Measure: Timely ART initiation (initiation within 3 months of enrollment) (assessed through the National Health Laboratory Service, pharmacy records, and medical chart abstraction).
Secondary Outcomes Measures: 1) HIV-1 RNA Suppression within the first 6 months of study enrollment (assessed through the National Health Laboratory Service).
2) Behavioral Factors associated with failure to initiate ART in a timely manner.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Cape Town、南非
- Desmond Tutu HIV Foundation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults living with HIV who are 18 years and older, who have not initiated ART within 3 months of learning their status
- ART naïve,
- Live within 60 km the testing center (due to prohibitive costs of following participants to remote locations);
- English or Xhosa speaking; and
- Eligible for treatment under current South Africa guidelines
Exclusion Criteria:
- Unable to provide informed consent (e.g., due to intoxication or mental incapacity,
- Persons less than 18 years of age,
- Women who report current pregnancy at the time of consent. We are choosing to not include pregnant women in this study, because the study's recruitment site refers pregnant clients to more specialized care facilities that may better suit their needs.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Standard of Care
Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200 Rand to complete all three surveys) only.
This group will not receive any additional engagement to care intervention.
Investigators intend to follow their clinical outcomes through medical registries, pharmacy data, and the National Health Laboratory Service (a national database for all individuals living with HIV in South Africa regarding engagement in care).
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有源比较器:Treatment Ambassador Intervention
Participants are administered baseline, 3 month, and 6 month questionnaires and provided with study incentive (100 Rand per survey plus an additional 200R to complete all three surveys).
For participants randomized to the intervention arm, they will immediately meet with a Treatment Ambassador to begin the 8 session intervention, which has components of motivational interviewing, peer-support, and peer navigation.
The protocol is detailed in a study manual that has been reviewed and undergone multiple iterative revisions to ensure cultural acceptability.
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This multi-component intervention, titled the "Treatment Ambassador Program," will target people living with HIV who have not initiated ART within 3 months of testing positive.
Our intervention will last for 8 sessions over 8-14 weeks, and will aim to address the three steams of influences on decision-making through a system of patient navigation and support with an assigned partner living with HIV who is trained in motivational interviewing.
It will be aimed at addressing barriers to ART initiation identified through our prior qualitative research, as framed through the Theory of Triadic Influence, by addressing the three streams of influences on decision-making through a system of patient navigation and support.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of Participants With Treatment Initiation at 3 Months After Study Enrollment
大体时间:3 months
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Treatment Initiation will be measured at 3 months through clinic records, pharmacy data, and the National Health Laboratory Service (NHLS), a national database in South Africa.
Primary data analysis will be an intent-to-treat analysis, which includes all randomized participants.
Of note, every attempt will be made to continue assessing participants even if they drop out of treatment.
In addition, investigators will replicate all analyses with the completers only.
The hypothesis that the intervention will yield higher rates of antiretroviral therapy (ART) initiation by the completion of the intervention will be tested using Fisher's exact test; the treatment effect estimate will be summarized in terms of a relative risk and 95% confidence interval.
Any baseline demographic or clinical variables identified as necessary covariates in preliminary analyses will be included in a logistic regression analysis that examines the main effect of treatment condition on the rates of ART initiation.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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HIV-1 RNA Suppression at 6 Months Post-enrollment
大体时间:6 months
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HIV-1 RNA will be measured at 6 months year post enrollment among participants who start ART to allow for sub-group analyses of people living with HIV who start ART in the intervention vs. control groups.
This will be accessible through NHLS and clinic data.
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6 months
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CD4
大体时间:6 months
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Mean CD4 counts at the 6 month assessment
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6 months
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Number of Participants With Intervention Acceptability
大体时间:Acceptability will be assessed during the intervention, an expected average timeframe of 8-14 weeks
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Satisfaction with intervention content, delivery, length using a client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options
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Acceptability will be assessed during the intervention, an expected average timeframe of 8-14 weeks
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Number of Participants With Intervention Feasibility
大体时间:Feasibility will be assessed during the intervention, an expected average timeframe of 8-14 weeks
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Intervention feasibility measured by attendance, retention for outcome assessments, fidelity
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Feasibility will be assessed during the intervention, an expected average timeframe of 8-14 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Time to Event Analysis of ART Initiation
大体时间:6 months
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Investigators will perform a Time to Event Analysis of Treatment Initiation and compare this between control and intervention arms. Data not available - only measured at 3 months to capture the importance of early treatment initiation |
6 months
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Number of Participants Who Reported Having Fewer Drinks at 6 Months Than at Baseline
大体时间:baseline and 6 months
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Assessed through self-reported measures of alcohol use: percent reporting fewer daily drinks at six months than at baseline. Participants were asked "How often do you have a drink containing alcohol (like beer, wine, or liquor)?" (Never, less than monthly, monthly....4 or more times a week). If they gave an answer other than "Never," they were then asked "How many drinks of any kind containing alcohol do you have on a typical day when you are drinking?" (1 or 2; 3 or 4...10 or more). Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
baseline and 6 months
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Short-form 8 (SF-8)
大体时间:baseline and 6 months
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Change in self-reported General Health over time. We compared the difference in scores between baseline and six months. The SF-8 is an eight question survey for measuring general physical and mental health. It is a shortened version of the SF-36 and the results are interpreted using the same methods. First, items are recorded on a 0 (lowest score) to 100 (highest score) scale, per a scoring key developed by RAND. Then, items in the same scale are averaged together so that each scale representing different elements of health has its own score. Scores represent the average for all questions the participant answered (the percentage of total possible score achieved). The higher the score, the better the participant's health. Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
baseline and 6 months
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Change in Self-reported Coping/Ability to Cope Over Time
大体时间:baseline and 6 months
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Brief COPE. We compared the difference in scores between baseline and six months. The Brief COPE was developed by Carver, C. S. and provides a condensed version of the full COPE tool which can be modified by choosing only select scales. We used a 2-item scale (both related to alcohol and drug use, min=1, max=4) based on factor analysis results. Higher scores are worse (more use of alcohol/drugs to feel better/get through). We averaged the 2 items to calculate the scale score. Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
baseline and 6 months
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Change in Self-reported Belief in ARV Efficacy/Trust in Antiretrovirals Over Time
大体时间:baseline and 6 months
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Perceptions of ARV Therapy Scale, HCSUS. We compared the difference in scores between baseline and six months. ARV efficacy was measured using an 8-item scale. For each item, min=1, max=4. Higher scores are better (higher belief in ARV efficacy). Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
baseline and 6 months
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Medical Outcomes Study (MOS) Social Support Survey
大体时间:baseline and 6 months
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Change in self-reported perceived social support over time. We compared the difference in scores between baseline and six months. The Social Support Survey contains four subscales (emotional/informational, tangible, affectionate, and positive social interaction) and an overall social support index. A higher score for any of the subscales or the index indicates higher levels of social support. Each subscale score is calculated by finding the average of all the scores in that subscale. The index is found by calculating the average of all the items. Social support was measured by asking eight questions each with a scale of one to five (five being the most support). The minimum score was 8 (least social support) and the maximum was 40 (most social support). Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
baseline and 6 months
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Patient-Health Questionnaire (PHQ)-9
大体时间:baseline and 6 months
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Change in self-reported depression over time. We compared the difference in scores between baseline and six months. Depression and anxiety symptoms and somatic complaints were measured using the 9-item Patient Health Questionnaire (PHQ), which scores DSM-IV criteria from 0 (not at all) to 3 (nearly every day). The subtotals are summed to create the total score. 0-4 is interpreted as minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 as moderately severe depression, and 20-27 as severe depression. Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
baseline and 6 months
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Change in Self-reported Internalized Stigma Over Time
大体时间:baseline and 6 months
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Internalized Stigma measure developed by Kalichman et al. We compared scores at baseline and six months. Internalized stigma was measured using the Internalized AIDS-Related Stigma Scale. This six-item scale is used to measure internalized stigma. Participants either agree (which scores them a "1") or disagree (which scores them a "0") to each item and the total scale score is computed as the sum of the items with a minimum score of 0 and maximum score of 6. The higher the score, the higher their internalized stigma. Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
baseline and 6 months
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Change in Self-reported Disclosure Concerns Over Time
大体时间:baseline and 6 months
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Disclosure concerns measure using Berger's HIV Stigma Scale. We modified the instrument to include eight statements related to disclosure concerns (i.e. I regret having told some people that I have HIV; I want to keep my HIV a secret) and participants responded disagree or agree. Disclosure concerns were measured by asking a set of eight questions, with a minimum score of 8 and a maximum score of 16. The higher the score, the greater the level of concern. We compared scores at baseline and six months. Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
baseline and 6 months
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Change in Self-reported Anticipated Stigma Over Time
大体时间:baseline and 6 months
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Anticipated Stigma measure developed by Earnshaw et al. We used the HIV Stigma Framework to measure anticipated HIV stigma. This instrument consists of items relating to anticipated stigma from friends, family, and healthcare workers. Items were scored on 5-point Likert-type scales (1=very unlikely, 5=very likely). Higher scores indicate greater anticipated stigma. Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. In this case, only one participant had not disclosed, but they were determined ineligible for the study. |
baseline and 6 months
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Change in Self-reported Barriers and Competing Needs Over Time
大体时间:Baseline and 6 months
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Barriers and Competing Needs measure developed by Craw JA et al. We compared results at baseline and six months. Barriers and competing needs were assessed by asking participants whether they had experienced each of 13 problems when medical care was needed in the past six months (e.g. not knowing where to find care, affordability of medications or transportation). The count of each participant's "yes" responses to these 13 yes/no items was taken as their score. Higher score means more barriers/competing needs. Note: 84 participants were enrolled into the study, but not all of them agreed to complete each survey. |
Baseline and 6 months
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合作者和调查者
调查人员
- 首席研究员:Ingrid Katz、Brigham and Women's Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Hospital Clinic of Barcelona完全的
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Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
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Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
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Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的
Treatment Ambassador的临床试验
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中
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Universitaire Ziekenhuizen KU LeuvenLaboratoires Thea招聘中