Overcoming Barriers to HIV/AIDS Care and ART Initiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
研究概览
简要总结
The study will evaluate interventions to improve engagement in HIV care following HIV diagnosis through a voluntary counseling and testing program. The specific aims are to (1) determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on ART initiation. The study will recruit 450 HIV-positive individuals from VCTs and randomize a third to standard counseling and referral, a third to receive CD4 testing at the VCT with results return by phone after 1 weeks, and a third to receive the same CD4 testing combined with peer counseling. These combined investigations will create a comprehensive understanding of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve measurable outcomes in applied settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •At least 18 years or older and
- •Testing HIV-positive for the first time at a voluntary counseling and testing (VCT) center.
- •Willing to receive counseling to encourage linkage to care at a comprehensive care center (CCC).
- •Willing to have a CD4 count test conducted at the enrollment visit.
- •Willing to have a telephone follow-up where they may receive additional counseling and/or have their CD4 count results returned to them.
- •Willing to be contacted over 1 year to determine if they linked to care.
排除标准
- •Previous positive HIV test.
- •Currently taking antiretroviral medications.
- •Currently pregnant (females only).
- •Currently participating in another research study or trial.
- •Not planning to remain in Nairobi for the next 12 months (not including short trips out of Nairobi).
研究组 & 干预措施
Standard of care
Standard HIV counseling and referral to care
CD4 testing
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week.
干预措施: Expedited CD4 testing (Behavioral)
CD4 testing plus peer counseling
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week. Additionally, a trained peer counselor provides supplemental counseling at the time of diagnosis and at the 1 week telephone follow-up.
干预措施: Expedited CD4 testing (Behavioral)
CD4 testing plus peer counseling
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week. Additionally, a trained peer counselor provides supplemental counseling at the time of diagnosis and at the 1 week telephone follow-up.
干预措施: Supplemental peer counseling (Behavioral)
结局指标
主要结局
Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
时间窗: 1 year
An interviewer administered questionnaire will be used to determine if each participant visited a comprehensive care center. Is so, the date of the first visit will be recorded. From this, the time from enrollment until first visit to a comprehensive care center will be calculated.
Number of days from study enrollment until initiation of antiretroviral therapy.
时间窗: 1 year
An interviewer administered questionnaire will be used to determine if each participant started antiretroviral therapy. Is so, the date of treatment initiation will be recorded. From this, the time from enrollment until treatment initiation will be calculated.
次要结局
- Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.(1 year)
- Measurement of CD4+ T-cell count.(1 year)
研究者
Brandon Guthrie
Assistant Professor, Global Health
University of Washington