Same-day ART Initiation Versus Standard of Care After Positive HIV-test Result in Rural Lesotho (CASCADE)
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|ClinicalTrials.gov Identifier: NCT02692027|
Recruitment Status : Completed
First Posted : February 25, 2016
Last Update Posted : February 19, 2019
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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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Other: Same-day ART initiation Other: Standard of care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Same Day Community-based 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|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||December 2018|
Active Comparator: Standard of care
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
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.
Experimental: Same-day ART initiation with less frequent follow-up visits
Proposition of same-day ART initiation with less frequent follow-up visits thereafter.
Other: Same-day ART initiation
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.
- Linkage to care [ Time Frame: 90 days ]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.
- Viral suppression [ Time Frame: 12 months ]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.
- 1-year retention in care [ Time Frame: 12 months ]Proportion confirmed dead (death record at clinic or confirmed by a first-grade relative), lost to follow-up (not attending the clinic 11-14 months after HIV-test and not confirmed dead), and retained in care (on ART, attends the clinic)
- Viral suppression under ART [ Time Frame: 6 months after ART initiation ]Viral load <100 copies/mL among those who started ART 5-7 months after ART-initiation.
- Change in body weight [ Time Frame: 12 months ]
- Change in CD4 cell count [ Time Frame: 12 months ]
- Change in haemoglobin [ Time Frame: 12 months ]
- New clinical WHO stage 3 or 4 events [ Time Frame: 12 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692027
|Butha-Buthe District Hospital|
|Principal Investigator:||Niklaus D Labhardt, MD, MIH||Swiss Tropical & Public Health Institute|
|Study Chair:||Tracy R Glass, PhD||Swiss Tropical & Public Health Institute|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Niklaus Labhardt, MD, MIH, Swiss Tropical & Public Health Institute|
|Other Study ID Numbers:||
|First Posted:||February 25, 2016 Key Record Dates|
|Last Update Posted:||February 19, 2019|
|Last Verified:||February 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Community-based initiation of antiretroviral therapy
Home-based HIV testing and counseling
Test and treat
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases