Same-day ART Initiation Versus Standard of Care After Positive HIV-test Result in Rural Lesotho

NCT02692027 | Completed Phase 3 DMC

• 1 other identifier: CASCADE
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural Lesotho. Participants who were tested HIV-positive during community-based HIV testing and counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1 with parallel assignment. Participants in the control arm follow the standard of care after a community-based HIV test result: They are referred to the nearest clinic where they will receive baseline laboratory testing and adherence counseling. After at least 2 clinic visits for adherence counseling they can start anti-retroviral therapy (ART). After ART-initiation they have to attend monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention arm are proposed same day community-based ART initiation combined with less frequent follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression at 12 months after having tested HIV-positive during the community-based HIV testing and counseling campaigns.

Conditions

HIV Infection

Keywords

Community-based initiation of antiretroviral therapy; Home-based HIV testing and counseling; Lesotho; Sub-sahara Africa; antiretroviral therapy; AIDS; Test and treat

Outcome Measures

Primary Outcomes (2)

• Linkage to care

  Linkage to care within 3 months after having been tested HIV positive during the HTC-campaign. A patient is considered to have linked to care if he/she attends the clinic at least once within 90 days after HIV diagnosis.

  90 days

• Viral suppression

  Viral suppression 12 months after positive HIV test result. Viral suppression is defined as a viral load \<100 copies/mL between 11 and 14 months after diagnosis of HIV-infection.

  12 months

Secondary Outcomes (6)

• 1-year retention in care

  12 months

• Viral suppression under ART

  6 months after ART initiation

• Change in body weight

  12 months

• Change in CD4 cell count

  12 months

• Change in haemoglobin

  12 months

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Standard of care in Lesotho. ART-initiation after at least two clinic visits for pre-ART counseling and monthly follow-up visits at the clinic thereafter.

Other: Standard of care

Same-day ART initiation with less frequent follow-up visits

EXPERIMENTAL

Proposition of same-day ART initiation with less frequent follow-up visits thereafter.

Other: Same-day ART initiation

Interventions

Same-day ART initiation OTHER

Participants tested HIV-positive during community-based HIV testing and randomized to the intervention group receive post-test counseling and on-the-spot clinical and laboratory assessment. Directly after the positive HIV-test result the study nurse assesses the participant clinically and performs point-of-care laboratory baseline testing. Thereafter, the participant receives a standardized short adherence counselling. After adherence counseling the participant is offered to start ART immediately. Those who decide to start ART during the visit or intend to start within seven days will receive a 30 day ART-supply and an follow-up appointment at the clinic within 12 to 16 days. In order to reduce travel time and transport cost, participants who are clinically stable, will have their follow-up visits and ART refills more widely spaced with appointments at 6 weeks, 3, 6, (9) and 12 months after ART initiation.

Same-day ART initiation with less frequent follow-up visits

Standard of care OTHER

Individuals found HIV-positive during the community-based HIV testing campaigns and randomized to the control arm receive post-test counselling and a referral letter with an appointment at their chosen health facility. On the first visit to the clinic, the participant receives laboratory assessment and a first adherence counselling session. The participant must then return to the clinic to receive his/her laboratory results and to undergo a second adherence counselling session. Once the participant has started ART, the first and second follow-up visits are scheduled for 14 and 28 days after ART initiation, respectively. Thereafter, follow-up visits are scheduled monthly until 6 months after ART initiation. If the participant is clinically stable, clinical follow-up visits may then be spaced to 3-monthly intervals, but refills of ART must still be collected on a monthly basis.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection newly diagnosed during community-based HTC-campaigns
• Never been on triple-ART
• Lives and/or works in the district of Butha-Buthe and declares to seek follow-up at one of the 6 health facilities involved in the study
• Signed written informed consent

You may not qualify if:

• Pregnant or breast-feeding
• Already enrolled in chronic care for another disease, such as tuberculosis or diabetes
• Clinical WHO-stage 4 or active tuberculosis
• Positive cryptococcal antigen test

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• SolidarMed - Swiss Organization for Health in Africa: collaborator
• Ministry of Health, Lesotho: collaborator
• District Health Management Team of Butha-Buthe, Lesotho: collaborator
• University of Basel: collaborator
• University of Geneva, Switzerland: collaborator

Study Sites (1)

Butha-Buthe District Hospital

Butha-Buthe, Lesotho

Location

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• Amstutz A, Brown JA, Ringera I, Muhairwe J, Lejone TI, Klimkait T, Glass TR, Labhardt ND. Engagement in Care, Viral Suppression, Drug Resistance, and Reasons for Nonengagement After Home-Based Same-Day Antiretroviral Therapy Initiation in Lesotho: A Two-Year Follow-up of the CASCADE Trial. Clin Infect Dis. 2020 Dec 17;71(10):2608-2614. doi: 10.1093/cid/ciz1126.

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• Labhardt ND, Ringera I, Lejone TI, Amstutz A, Klimkait T, Muhairwe J, Glass TR. Effect and cost of two successive home visits to increase HIV testing coverage: a prospective study in Lesotho, Southern Africa. BMC Public Health. 2019 Nov 1;19(1):1441. doi: 10.1186/s12889-019-7784-z.

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• Labhardt ND, Ringera I, Lejone TI, Klimkait T, Muhairwe J, Amstutz A, Glass TR. Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial. JAMA. 2018 Mar 20;319(11):1103-1112. doi: 10.1001/jama.2018.1818.

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• Labhardt ND, Ringera I, Lejone TI, Masethothi P, Thaanyane T, Kamele M, Gupta RS, Thin K, Cerutti B, Klimkait T, Fritz C, Glass TR. Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial). BMC Public Health. 2016 Apr 14;16:329. doi: 10.1186/s12889-016-2972-6.

  PMID: 27080120 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Niklaus D Labhardt, MD, MIH

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

• Tracy R Glass, PhD

  Swiss Tropical & Public Health Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MIH

Study Record Dates

• First Submitted: February 21, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

LE (1)