Clinical trial NCT02271074: Thol'Impilo: Bringing People Into Care
Official title: An Evaluation of Strategies to Accelerate Entry-into-care Following HIV Diagnosis Among Adults in Gauteng and Limpopo Provinces, South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Care
Treatment
Retention
Implementation Science
Lead sponsor: The Aurum Institute NPC
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Johns Hopkins University
name: London School of Hygiene and Tropical Medicine
name: University of Witwatersrand, South Africa
First posted: 2014-10-22
Enrollment: 2398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main objective of this study is to compare the effectiveness of combinations of three patient-oriented strategies, compared to the standard of care, to increase the proportion of patients who enter-into-care for HIV within 90 days of testing HIV positive.

Detailed description: Background:

Mortality remains high among individuals with HIV in South Africa largely due to low CD4 at initiation of combination antiretroviral therapy (cART) or failure to initiate cART altogether. The problem of advanced HIV at the time of entry-into-care persists despite increases in CD4 count initiation thresholds and higher CD4 counts among individuals testing HIV positive at HIV counselling and testing services (HCT). A reason for the discord between CD4 at HCT and CD4 at cART initiation is a failure to effectively link people who test positive into HIV care; less than half of individuals testing HIV positive enter HIV care within 3-6 month of HIV diagnosis. However, not only do these delays increase HIV associated mortality, delays from testing positive to entry-into-care for HIV also reduces the ability of test-and-treat strategies to reduce HIV transmission through HIV treatment.

Study Design:

Thol'impilo is an open (non-masked) individually-randomized implementation science evaluation of the effectiveness and cost-effectiveness of combinations of three strategies to increase timely entry-into-care for HIV compared to the standard of care. Participants are randomly assigned to one of four arms to increase timely entry into care: (1) standard of care, (2) point-of-care CD4 and transport assistance, (3) point-of-care CD4 and care facilitator and (4) point-of-care CD4 alone.

Sample size:

The study aims to enrol 2500 participants (i.e. 650 participants per arm).

Setting:

The study is built onto the current community-based HIV Counselling and Testing (HCT) services. The HCT units serve peri-urban townships and informal settlements, rural farm workers, and both urban and rural communities.

Eligibility criteria: Inclusion Criteria:

* aged 18 years and older, diagnosed HIV positive at enrolling mobile HCT units, no prior self-reported registration at a health care facility for HIV care, provide consent for participation

Exclusion Criteria:

* self-reported prior or current registration as an HIV patient at a healthcare facility

Primary outcomes:
measure: Time to entry into HIV care
timeFrame: 90 days
Secondary outcomes:
measure: Proportion entering care
timeFrame: 90 days
measure: Time to entry into HIV care
timeFrame: 180 days
measure: Mortality
timeFrame: 6 and 12 months
measure: Cost per additional participant entering into care
timeFrame: Costs will be measured over a 12 month horizon and entry into care will be measured over a 90 day period
Other outcomes:
measure: Time to ART initiation
timeFrame: 90 days
Locations:
city: Johannesburg
country: South Africa
facility: The Aurum Institute NPC
state: Gauteng
Study officials:
affiliation: The Aurum Institute NPC
name: Violet Chihota, PhD
role: STUDY_DIRECTOR
References:
citation: Hoffmann CJ, Mabuto T, Ginindza S, Fielding KL, Kubeka G, Dowdy DW, Churchyard GJ, Charalambous S. Strategies to Accelerate HIV Care and Antiretroviral Therapy Initiation After HIV Diagnosis: A Randomized Trial. J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):540-547. doi: 10.1097/QAI.0000000000001428.