Village-based vs Clinic-based ART Care - a Cluster Randomized Controlled Trial in Lesotho (VIBRA)
HIV/AIDS
About this trial
This is an interventional health services research trial for HIV/AIDS focused on measuring HIV, Village Health Worker, Differentiated Care, Lesotho, Africa, antiretroviral therapy
Eligibility Criteria
Inclusion Criteria for clusters:
- the cluster is clearly confined to the catchment area of one of the study clinics
- the cluster has at least one registered VHW who is willing to participate and fulfills the following criteria:
- is at least 18 years of age
- has adequate reading and writing skills
- successfully passes the training assessment
- village authority (village chief) is willing to participate in trial
Exclusion criteria for clusters:
- Village authority (=village chief) opposed to trial participation (verbal assent)
- Village health worker opposed to trial participation or not fulfilling the minimum requirements mentioned above
Inclusion Criteria for individuals:
- Individual is a household member of the visited households of the respective clusters
- Individual is confirmed HIV-positive
- Individual has never taken ART (ART-naïve) or has stopped ART more than 30 days prior (ART-defaulters)
- Individual is ≥10 years old and has a body weight of ≥35kg
- Individual is not in care for high blood pressure or diabetes (high blood sugar)
- HIV-positive individual wishes to get care outside the study districts
Exclusion criteria individuals:
- The household member is absent at the time of the campaign
- HIV-positive individual is taking ART or stopped less than 30 days ago
- HIV-positive individual is physically, mentally, or emotionally not able to participate in the study, in the opinion of the investigators or study staff
- HIV-positive individual is in care for high blood pressure (hypertension) or high blood sugar (diabetes) - proof of documentation or medication needed
- HIV-positive individual wishes to get care outside the study districts
Sites / Locations
- District of Butha-Buthe
- District of Mokhotlong
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard of Care
Village-based ART refill
Offer of home-based same-day ART initiation Clinic-based ART visit/refill Who: Nurse Where: Nurse-led health facility When: Follow-up interval of max. 3 months What: TB screening, Screening for other opportunistic infections, Screening for ART-related toxicities, adherence assessment, assessment whether patient visited any medical facility since last appointment, addressing basic psychosocial problems, ART (+CTX/IPT) dispensing No SMS intervention
Offer of home-based same-day ART initiation Offer of Village-based ART visit/refill Who: VHW Where: At VHW's home* When: Follow-up interval of max. 3 months What: TB screening, Screening for other opportunistic infections, Screening for ART-related toxicities, adherence assessment, assessment whether patient visited any medical facility since last appointment, addressing basic psychosocial problems, ART (+CTX/IPT) dispensing *Except at 6 and 12 months follow-up: visit at health facility for laboratory assessment (viral load) Offer of Individually customized SMS Monthly reminder SMS: to pick up ART SMS communicating VL result