Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201906476052236 Date of Approval: 24/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sinako: Households and HIV
Official scientific title Building HIV competent households: A sustainable answer to HIV prevention and treatment challenges in South Africa.
Brief summary describing the background and objectives of the trial The response to the HIV epidemic in South Africa is complicated by human resource shortages in healthcare. Building health-enabling households with the capacity to actively stimulate a lifestyle that fosters health offers a potential strategy to tackle South Africa's current prevention and treatment challenges. Research is thus urgently needed on how to create 'HIV competent households', which adopt preventive strategies and help HIV positive members to adhere to treatment and remain in care. Aim of this project is to investigate to what extent and how an intervention delivered by community health workers can: (1) increase HIV competence in people living with HIV (PLWH) and their households, and subsequently (2) improve prevention (PLWH + household) and treatment (PLWH) outcomes. Methodologically, this study adopts a longitudinal mixed methods design. To respond to our quantitative research aims, data from the cluster randomized controlled trial, the "Sinako: Households and HIV" study, will be analysed, using latent cross-lagged modelling. To construct a comprehensive picture of the mechanisms underlying the impact of the intervention on the household and the PLWH, various qualitative data sources will be used (i.e., participatory observations and repeated in-depth interviews with PLWH; and their household members).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SINAKO
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 01/07/2019
Actual trial start date
Anticipated date of last follow up 01/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 640
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sinako 7 sessions, once a month. Each session is estimated to take about 1 hour In addition to the pill count and home assessment of the control group, the intervention group will receive the following sessions: The first intervention visit will focus on living with HIV by discussing and improving HIV-related knowledge and by exploring the feelings of the person living with HIV (PLWH) about living with HIV and taking ART. An assessment of the household support system of the PLWH concludes this session (genogram). In the second intervention visit, the community health worker (CHW) and PLWH will explore challenges the patient experiences with respect to antiretroviral treatment (ART) adherence. Facilitated by the CHW, the patient will develop an adherence plan to adhere to ART. The third intervention visit focuses on communication of the PLWH with his or her household. After exploring communication patterns in the household, the PLWH will be trained to apply positive communication skills to share his/her HIV-related knowledge and to discuss HIV-related topics. In the fourth intervention visit, the focus will be on disclosure of the PLWH’s HIV status. Revisiting the genogram with respect to disclosure, the advantages and disadvantages are discussed of disclosing members of the genogram. Based on this discussion, the CHW guides the patient in a disclosure exercise. After exploring the elements that are contributing the HIV competency in the fifth session, the CHW will support the patient to become change agents in the household aiming to stimulate HIV competency. In the sixth intervention visit, the CHW will facilitate a discussion on how the patient can foster ownerships of HIV and responsibility for safe sexual practices, testing and adherence to ART. The seventh and last intervention visit, will focus on the re-assessment the (1) self-management skills and (2) the HIV competence of the household. A long-term plan of support is developed, so that the PLWH is equipped to self-manage his or her treatment within a supportive household. 320
Control Group Sinako 6 sessions, once a month Each session is expected to take 20 minutes In the first control session, the patient will receive a home assessment in which the household situation of the patient is assessed. In the remaining sessions, the community health worker (CHW) counts the ART medication to assess the adherence. The CHW also supports the PLWH, if he/she has a question with respect to the treatment. 320 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria encompass - a minimum age of 18 years; - having commenced ART for the first time within four weeks prior to the study; - attending one of the clinics part of this cluster-RCT; - and having a household member above 18 years old. The household includes all those persons who lived under this “roof” or within the same structure at least four nights per week out of the past month. No specific exclusion criteria. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/02/2018 Ethics Committee of the Social Sciences and Humanities
Ethics Committee Address
Street address City Postal code Country
Lange Winkelstraat 40 Antwerp 2000 Belgium
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/06/2019 Biomedical Science Research Ethics Committee of the University of the Western Cape
Ethics Committee Address
Street address City Postal code Country
Private Bag X17 Bellville 7535 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes for this study will be (1) patient’s viral load and (2) ART adherence (measured by the Adherence to Combination Therapy Questionnaire (ACTG). Two time points, before and after the intervention.
Secondary Outcome Secondary outcomes will be measured at the individual level and the household level. At the individual level, the PLWH questionnaire assesses HIV knowledge, condom use, quality of life, self-management, perceived social support and full disclosure (to all household members). At the household level, the outcomes are measured in a household questionnaire. This questionnaire will be presented as a general health survey, and conducted by another fieldworker than the individual questionnaire – so as to avoid inadvertent disclosure. Outcomes measured at the household level, include HIV knowledge; condom use; HIV-related stigma; communication about HIV; Household functioning; HIV testing; Provide support to a household member living with HIV. These outcomes are included as indications of household comfort with HIV and communicating about HIV and could be considered as proxy measures for HIV competency at the household level. Viral load data will be captured from the medical register, while data on ART adherence and the other individual- and household-level outcomes will be collected from the enrolled individual independently by the research team. The secondary outcomes will be measured at two time points: before and after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
School of Public Health University of the Western Cape Robert Sobukwe Rd, Bellville Cape Town 7535 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
VLIR UOS Research Foundation Flanders Julien Dillensplein 1 Brussels 1060 Belgium
Research Foundation Flanders Egmontstraat 5 Brussels 1000 Belgium
National Research Foundation South Africa Meiring Naude Rd Pretoria South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Antwerp Sint Jacobstraat 2 Antwerp 2000 Belgium University
Secondary Sponsor University of the Western Cape Rober Sobukwe road Cape Town 7535 South Africa University
COLLABORATORS
Name Street address City Postal code Country
TB HIV Care Association Adderley Street Cape Town 8000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edwin Wouters edwin.wouters@uantwerpen.be +27219592243 Sint Jacobstraat 2
City Postal code Country Position/Affiliation
Antwerpen 2000 Belgium Professor University of Antwerp
Role Name Email Phone Street address
Scientific Enquiries Lucia Knight lknight@uwc.ac.za +27219592243 Robert Sobukwe road
City Postal code Country Position/Affiliation
Cape Town 7535 South Africa Professor at the University of the Western Cape and local PI for this project
Role Name Email Phone Street address
Public Enquiries Caroline Masquillier caroline.masquillier@uantwerpen.be +27219592243 Sint Jacobsstraat 2
City Postal code Country Position/Affiliation
Antwerp 2000 Belgium Postdoctoral researcher at the University of Antwerp
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Within 12 months of the study completion date, we will provide a summary of the results or a link to summary results within the trial registration record. Study Protocol Within 12 months of the study completion date, we will provide the additional document types as described above. Aim is to provide a summary of the results or a link to summary results within the trial registration record. We will also aim to publish the study protocol so that it can be accessed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information