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Improving Clinic Attendance for Medication Collection Among HIV Positive Individuals in Nepal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03367130
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
Asian Development Bank Japan Scholarship Program
Open Society Institute
Information provided by (Responsible Party):
Rakesh Ayer, Tokyo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Antiretroviral Therapy HIV Seropositivity Behavioral: Mobile phone reminder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: This study will be a double blinded RCT. HIV-positive individuals will be blinded to allocation group. Further, those who deliver the intervention will be blinded to the allocation. Intervention and control groups will receive similar intervention strategies. Only the content of the interventions will be different. Therefore, it is difficult for HIV-positive individuals to tell if they are receiving intervention or control. The outcome assessor will be masked to the allocation of each HIV-positive individual by using trial identity numbers. Only the principal researcher will have complete access to all the information.
Primary Purpose: Health Services Research
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
Actual Study Start Date : October 14, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
HIV-positive individuals will receive the standard HIV care following the national ART guidelines. In addition, the intervention group will receive mobile phone calls. A mobile phone reminder will be made two days prior to their scheduled appointment for pills pick up. Trained research assistants will remind them of their scheduled clinic appointment of pills pick up. If the first call is missed, the second call will be made within the same day, if the second call is also missed, the final call will be made next day. The intervention will be delivered over the period of six months. Outcome assessors will not be involved in the phone calls.
Behavioral: Mobile phone reminder
Intervention described already in arm/group descriptions.

Placebo Comparator: Control
Control group will also receive the standard HIV care following the national ART guidelines and phone calls educating them on healthy living. Phone calls will be made once a month.
Behavioral: Mobile phone reminder
Intervention described already in arm/group descriptions.




Primary Outcome Measures :
  1. Clinic attendance for pills pick up [ Time Frame: six months. ]

    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.



Secondary Outcome Measures :
  1. Delay in pills pick up [ Time Frame: Six months. ]
    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.

  2. Medication adherence [ Time Frame: Six months. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367130


Locations
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Nepal
Seti Zonal Hospital
Dhangadi, State 7., Nepal
Sponsors and Collaborators
Tokyo University
Asian Development Bank Japan Scholarship Program
Open Society Institute
Investigators
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Study Chair: Masamine Jimba, PhD, MD, MPH Tokyo University
Publications:
UNAIDS. Global AIDS update 2016. Geneva, Switzerland: Joint United Nations Programme on HIV/AIDS; 2016.
WHO. World health organization global strategy for the surveillance and monitoring of HIV drug resistance. Geneva, Switzerland: World Health Organization, 2012.
NCASC. Factsheet 1: HIV Epidemic Update of Nepal, as of December 2015. National Center for AIDS and STD Control. Kathmandu, Nepal, 2016.
NCASC. Factsheet 6: HIV Care and Antiretroviral Therapy (ART) Services in Nepal, as of July 2016. National Center for AIDS and STD Control. Kathmandu, Nepal, 2016.
Kathmandu Post. Mobile subscriptions outnumber population, 2016.
NCASC. National consolidated guidelines for treating and preventing HIV in Nepal. National Center for AIDS and STD Control. Kathmandu, Nepal, 2014.
NCASC. National Antiretroviral Therapy Guidelines. National Center for AIDS and STD Control. Kathmandu, Nepal, 2012.
NCASC. National consolidated guidelines for treating and preventing HIV in Nepal. National Center for AIDS and STD Control. Kathmandu, Nepal: Ministry of health and population, 2014.
David J. Torgerson CJT: Designing Randomised Trials in Health, Education and the Social Sciences. New York. Palgrave Macmillan, 2008.

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Responsible Party: Rakesh Ayer, Mr., Tokyo University
ClinicalTrials.gov Identifier: NCT03367130    
Other Study ID Numbers: 11711
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rakesh Ayer, Tokyo University:
Antiretroviral therapy, clinic attendance, Nepal
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases