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

PHASE3CompletedINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

October 31, 2017

Study Completion Date

December 31, 2018

Conditions
HIV Infection
Interventions
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."

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."

Trial Locations (1)

Unknown

Butha-Buthe District Hospital, Butha-Buthe

All Listed Sponsors
collaborator

SolidarMed - Swiss Organization for Health in Africa

UNKNOWN

collaborator

Ministry of Health, Lesotho

OTHER_GOV

collaborator

District Health Management Team of Butha-Buthe, Lesotho

OTHER

collaborator

University of Basel

OTHER

collaborator

University of Geneva, Switzerland

OTHER

lead

Swiss Tropical & Public Health Institute

OTHER

NCT02692027 - Same-day ART Initiation Versus Standard of Care After Positive HIV-test Result in Rural Lesotho | Biotech Hunter | Biotech Hunter