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: www.pactr.org
Trial no.: PACTR201811878799717 Date of Approval: 20/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mobile phone SMS for adherence support for hypertension in South African adults in care for HIV infection
Official scientific title MObile Phone text messages to support Hypertension treatment ADherence in adults attending HIV treatment centres in the Western Cape Province of South Africa: a pilot study – The MOPHADHIV trial
Brief summary describing the background and objectives of the trial Care of people with HIV across sub-Saharan Africa (SSA) is provided through dedicated parallel health streams, primarily designed to address HIV and related infectious co-morbidities. Consequently, the opportunity of addressing co-morbid non-communicable disease (NCD) is not fully realized in this population in regular contacts with the health system. Integration of HIV and NCD care has been suggested to improve the co-detection and co-management of co-morbid HIV and NCDs. Key to the success of this integration is a better understanding of the burden and drivers of NCDs in people with HIV, and appropriate strategies for promoting their care without compromising HIV specific care. The current study will test the hypothesis that treatment support in the form of automated text-messaging can improve the uptake of- and adherence to blood pressure lowering medications, and result in improved outcomes of hypertension care without compromising ongoing HAART in adult South Africans with co-morbid HIV and hypertension. Our principal research question is: Among South African adults with co-morbid HIV infection and hypertension, can treatment support in the form of automated text-messaging improve the uptake of- and adherence to blood pressure lowering medications, and result in improved outcomes of hypertension care without compromising ongoing HAART? Additional research questions include: 1) What patients, health system and other factors are likely to affect the wider uptake and dissemination of evidence from the current study in South Africa and other countries in the region? 2) What are the estimated impact and cost-effectiveness of this approach in improving the outcome of hypertension care in people with HIV in South Africa and other countries in the region with high burden of co-morbid HIV infection and hypertension?
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MOPHADHIV
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 01/04/2019
Actual trial start date
Anticipated date of last follow up 01/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 1300
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 Dynamic (adaptive) random allocation such as minimization Central randomisation by phone/fax Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS adherence support These messages will be sent once a week for 52 weeks. 52 weeks In the current study, the treatment group will receive messages to motivate collecting and taking medicine and to provide education about and motivation for secondary adherence, in particular, on healthy lifestyle choices (nutrition, physical activity, stress management). Additional reminders will be sent when medicine are ready for collection or about scheduled clinic appointment. 750
Control Group Usual care Once once The usual care group will only receive a welcome message, a message confirming enrolment and other SMS text-messages about participation in the trial. Delivery of SMS text-messages will be automatically tracked and if undelivered, a research assistant, blinded to group allocation, would contact the number of a friend or relative to obtain a new mobile phone number. 750 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients will be included if the following are satisfied: A) Diagnosed with HIV and Hypertension; B) on ART and on blood pressure lowering medication (or about to start); C) BP at recruitment >140/90 mmHg; D) within 8 weeks of a viral load test (to offset the cost of baseline viral load and reduce the overall cost of the study); E) accessing care for both HIV and hypertension at selected sites; F) have regular access to a mobile phone and able to access SMS text messages; G) >18 years of age and willing to participate and give written informed consent. Exclusion criteria: A) requirering specialist care for hypertension; B) self-reported pregnancy or within three months post-partum; C) very high BP (systolic >220 mmHg or diastolic >120 mmHg) or symptoms suggestion hypertensive emergency; D) Active malignancy or ongoing treatment for malignancy; E) Acutely unwell patients. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 09/05/2017 SAMRC Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive, Parow Valey Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean difference in systolic and diastolic blood Pressure Baseline and after 52 weeks of follow-up
Secondary Outcome 1) uptake and adherence to BP medications, 2) uptake an adherence to HIV specific medications, 3) mean change in lipid variables, 4) mean change in CD4 count and viral load, 4) mean change in adiposity variables, 5) change in kidney function; Tertiary - 1) Descriptive analysis of the process involved in the intervention, 2) Economic analysis, 3) Quality of life. Baseline and after 52 weeks of follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mitchells Plain Community Health Centre ARV Clinic First Avenue, Eastridge, Mitchells Plain Cape Town 7785 South Africa
Klipfontein Community Health Centre ARV Clinic Klipfontein Trust, Thaba Nchu, Free Cape Town 9780 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Anna van Saksenlaan 51, 2593 HW The Hague The Hague 2593 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Francie van Zijl Drive, Parow Valey Cape Town 7505 South Africa Research Organisation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Andre Pascal KENGNE andre.kengne@mrc.ac.za 0027219380841 Francie van Zijl Drive, Parow Valey
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Director NCDRU SAMRC
Role Name Email Phone Street address
Public Enquiries Anniza de Villiers Anniza.DeVilliers@mrc.ac.za 0027219380840 Francie van Zijl Drive, Parow Valley
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Scientist SAMRC
Role Name Email Phone Street address
Scientific Enquiries Andre Pascal Kengne andre.kengne@mrc.ac.za 0027219380841 Francie van Zijl Drive, Parow Valley
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Director NCDRU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 20/11/2018 update Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)