HIV Infections Clinical Trial
Official title:
Integrating Mobile Phone-Based Intervention With Test and Treat Strategy to Improve Clinic Attendance for Antiretroviral Pills Pick Up Among HIV Positive Individuals in Nepal: A Randomized Controlled Trial
NCT number | NCT03367130 |
Other study ID # | 11711 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 14, 2017 |
Est. completion date | June 30, 2018 |
Verified date | September 2018 |
Source | Tokyo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Antiretroviral therapy (ART) has been a game changer in the context of HIV-epidemic. From 2005 to 2015, HIV-related deaths have fallen by 45% thanks to ART. However, ART's success heavily depends on HIV-positive individuals' high adherence to it. This includes clinic attendance for various purposes. It is necessary among HIV-positive individuals for their antiretroviral (ARV) pills pick up, monitoring of their treatment outcomes, and treatment of their opportunistic infections. Among them, ARV pills pick up is the major reason for the ART clinic attendance. Improving clinic attendance for pills pick up remains one of the key challenges to ART programs. The World Health Organization (WHO) recommends more than 90% on-time ARV pills pick up as per the early warning indicators of HIV-drug resistance. Among six Asian countries, none of the 1048 clinics under the study could meet the WHO target. Among HIV-positive individuals, clinic attendance for pills pick can be improved by using mobile phones. Those who receive mobile phone reminders are two times more likely to attend their clinics regularly than those who did not receive such reminders. Nepal belongs to a low-income country and is facing a similar problem, too. In 2015, approximately 39,000 people were estimated to be living with HIV and ART coverage was limited to only 31.5%. In the same year, only 32% of the HIV-positive individuals attended their clinics regularly for ARV pills pick up. Like other countries, one of the potential strategies is to use mobile phones effectively in Nepal. Mobile phones have been very widely used in Nepal. In 2016, Nepal had 27.9 million mobile phone users, against the population of 26.5 million. Under such a context, mobile phone reminders can be effective to improve clinic attendance among HIV-positive individuals. However, the effectiveness of such interventions barely remains examined by using a randomized controlled trial. This study evaluates the effectiveness of mobile phone reminder intervention on improving clinic attendance for ARV pills pick up and medication adherence among HIV-positive individuals on ART following the implementation of test and treat strategy in Nepal.
Status | Completed |
Enrollment | 468 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria - Eligibility criteria 1. be 18 years or over; 2. own a mobile phone; 3. started treatment following test and treat strategy; and 4. under the first line ART regimen - Exclusion criteria HIV-positive individuals will be excluded if they have severe physical and mental illnesses. |
Country | Name | City | State |
---|---|---|---|
Nepal | Seti Zonal Hospital | Dhangadi | State 7. |
Lead Sponsor | Collaborator |
---|---|
Tokyo University | Asian Development Bank Japan Scholarship Program, Open Society Institute |
Nepal,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinic attendance for pills pick up | Clinic attendance adherence rate will be used to assess the clinic attendance. The rate will be based on the rate of total days adhered to the total scheduled days. An attendance will be called 'adhered', when they maintained an attendance in less than or equals to two days among scheduled days. Information on clinic attendance will be obtained from HIV-positive individuals' treatment and care files. Clinic attendance will be measured over the period of six months after the intervention. Dichotomous measure will be used to assess the clinic attendance for pills pick up. A 100% adherence rate will be used to define regular clinic attendance and missing any appointment(s) will be categorized as inconsistent clinic attendance. |
six months. | |
Secondary | Delay in pills pick up | Delay in pills pick up will be assessed with the number of days late from the scheduled appointment to the actual date of medication collection. | Six months. | |
Secondary | Medication adherence | Medication adherence will be measured at the baseline and at the end of the intervention. The questionnaire will be adopted from AIDS Clinical Trials Group. Intake of >95% of the doses of prescribed will be defined as adherent and intake of <= 95% of the doses will be defined as non-adherent. Possible reasons will also be collected for missing to take medications. | Six months. |
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