HIVMAHILANCT02319330
Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
A study testing Nurse-delivered mobile phone counseling intervention and Treatment as Usual in people with HIV and Depression, run by Yale University at 1 site in India.
Trial summary
The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Depression
- What is being tested?
- Nurse-delivered mobile phone counseling intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 25 Sep 2013to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+ women starting ART
- Willing to be contacted by mobile phone
- Speaks English or Hindi or Kannada
- Screens positive for depressive symptoms or psychosocial risk factors
- Able to provide informed consent
Who cannot join
- Unable to participate in study visits
- Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.
Read the detailed description
The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors. Over the past decade there have been dramatic improvements in HIV prevention and access to life-saving antiretroviral therapy (ART). Yet, deficits in adherence to the spectrum of HIV care pose significant barriers to success. Women are at a particular disadvantage. Gender inequality, physical and situational factors place many women at increased risk for HIV acquisition and poor mental health and interrelated psychosocial co-factors (depression, gender-discrimination, violence, lack of social support, etc.) that are well established correlates of poor adherence and retention in HIV care. Recent studies have shown alarmingly high rates of loss to follow-up for these women, particularly in the transition after delivery, between PMTCT and lifelong HIV care services. Preliminary work indicates that a theory-guided adherence phone intervention that can be easily integrated and sustained as a component of routine ART Centre services is well suited for the target population, but it needs to be adapted to the sociocultural context. Following initial formative work to refine the intervention for delivery in India, clinic nurses will be trained to deliver the intervention, and the feasibility, fidelity and preliminary efficacy of the novel application of the intervention will be evaluated in a randomized trial. After baseline assessment, women (n=120) will be randomly assigned to treatment as usual (TAU) or TAU plus the phone intervention (delivered over 16 weeks) and outcomes will be evaluated at 6, 14, 24, 36 weeks post-randomization. If the promising mobile phone intervention developed and pilot tested in this project shows promise in this Phase 1 study as we expect, the efficacy and cost of the intervention will then be evaluated in a large scale, multi-site study. If successful, an extremely practical approach will be available to improve the prevention and treatment outcomes of women with HIV and co-morbid mental health problems in India.
- Conditions
- HIV, Depression
- Being tested
- Nurse-delivered mobile phone counseling intervention, Treatment as Usual
- Keywords
- HIV, Adherence, Mental health, Depression, Women, Mobile phone technology, eHealth, India
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-delivered mobile phone counseling interventionBehavioural
Multi-dimensional, patient-centered counseling approach used to build patient-provider rapport, establish sources of support, and enable and empower problem solving to address inter-related, multi-tiered barriers to care.
Treatment as UsualBehavioural
Routine HIV clinic-based counseling
| Study group | Role | What they receive |
|---|---|---|
| Phone counseling intervention | Experimental | Treatment as usual (TAU) plus a nurse-delivered mobile phone counseling intervention delivered at weeks 1 to 12, 14, and 16 post-randomization. Receives: Behavioral: Nurse-delivered mobile phone counseling intervention; Behavioral: Treatment as Usual |
| Treatment as Usual | Active comparator | Routine HIV clinic-based counseling Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
HIV-1 RNA copies per millilitre of blood plasma
Measured: 6 months post-randomization
Secondary outcomes (8)
Medication adherence
Self-reported adherence to HIV medications
Measured: 6 weeks post-randomization
Mental health (Survey)
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
Measured: 6 weeks post-randomization
Medication adherence (Self-reported)
Self-reported adherence to HIV medications
Measured: 14 weeks post-randomization
Medication adherence (Self-reported)
Self-reported adherence to HIV medications
Measured: 24 weeks post-randomization
Medication adherence (Self-reported)
Self-reported adherence to HIV medications
Measured: 36 weeks post-randomization
Mental health (survey)
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
Measured: 14 weeks post-randomization
Mental health
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
Measured: 24 weeks post-randomization
Mental health
Survey measures of symptoms of depression, anxiety and cognitive representation of illness
Measured: 36 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study start25 Sep 2013
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Nancy R Reynolds, PhD, Principal investigator, Yale UniversityPrabha Chandra, MD, Principal investigator, National Institute of Mental Health and Neuro Sciences (NIMHANS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319330
- Sponsor's protocol ID
- 1301011297
- Other IDs
- R21MH100939
- Acronym
- MAHILA
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2014
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Reynolds NR, Satyanarayana V, Duggal M, Varghese M, Liberti L, Singh P, Ranganathan M, Jeon S, Chandra PS. MAHILA: a protocol for evaluating a nurse-delivered mHealth intervention for women with HIV and psychosocial risk factors in India. BMC Health Serv Res. 2016 Aug 4;16(a):352. doi: 10.1186/s12913-016-1605-1.
PubMed 27491288Satyanarayana VA, Duggal M, Jeon S, Singh P, Desai A, Chandra PS, Reynolds NR. Exploring the feasibility, acceptability and preliminary effects of a nurse delivered mhealth intervention for women living with HIV in South India: a pilot randomized controlled trial. Arch Womens Ment Health. 2024 Oct;27(5):751-763. doi: 10.1007/s00737-024-01462-0. Epub 2024 Apr 17.
PubMed 38630259Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
PubMed 32779730
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women
- ClinicalTrials.gov ID
- NCT02319330
- Acronym / sponsor ID
- MAHILA / 1301011297
- Conditions
- HIV, Depression
- Keywords
- HIV, Adherence, Mental health, Depression, Women, Mobile phone technology, eHealth, India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health and Neuro Sciences, India, National Institute of Mental Health (NIMH)
- Study start
- 25 Sep 2013 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors.
Detailed description
The overall objective of this project is to demonstrate that a low cost, cell phone-delivered intervention is a promising, feasible and acceptable way to improve the prevention and treatment outcomes of women in India who are affected by HIV and inter-related mental health and psychosocial risk factors. Over the past decade there have been dramatic improvements in HIV prevention and access to life-saving antiretroviral therapy (ART). Yet, deficits in adherence to the spectrum of HIV care pose significant barriers to success. Women are at a particular disadvantage. Gender inequality, physical and situational factors place many women at increased risk for HIV acquisition and poor mental health and interrelated psychosocial co-factors (depression, gender-discrimination, violence, lack of social support, etc.) that are well established correlates of poor adherence and retention in HIV care. Recent studies have shown alarmingly high rates of loss to follow-up for these women, particularly in the transition after delivery, between PMTCT and lifelong HIV care services. Preliminary work indicates that a theory-guided adherence phone intervention that can be easily integrated and sustained as a component of routine ART Centre services is well suited for the target population, but it needs to be adapted to the sociocultural context. Following initial formative work to refine the intervention for delivery in India, clinic nurses will be trained to deliver the intervention, and the feasibility, fidelity and preliminary efficacy of the novel application of the intervention will be evaluated in a randomized trial. After baseline assessment, women (n=120) will be randomly assigned to treatment as usual (TAU) or TAU plus the phone intervention (delivered over 16 weeks) and outcomes will be evaluated at 6, 14, 24, 36 weeks post-randomization. If the promising mobile phone intervention developed and pilot tested in this project shows promise in this Phase 1 study as we expect, the efficacy and cost of the intervention will then be evaluated in a large scale, multi-site study. If successful, an extremely practical approach will be available to improve the prevention and treatment outcomes of women with HIV and co-morbid mental health problems in India.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone counseling intervention | Experimental | Behavioral: Nurse-delivered mobile phone counseling intervention, Behavioral: Treatment as UsualTreatment as usual (TAU) plus a nurse-delivered mobile phone counseling intervention delivered at weeks 1 to 12, 14, and 16 post-randomization. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualRoutine HIV clinic-based counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV+ women starting ART
- Willing to be contacted by mobile phone
- Speaks English or Hindi or Kannada
- Screens positive for depressive symptoms or psychosocial risk factors
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Unable to participate in study visits
- Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-delivered mobile phone counseling interventionMulti-dimensional, patient-centered counseling approach used to build patient-provider rapport, establish sources of support, and enable and empower problem solving to address inter-related, multi-tiered barriers to care. | Behavioural | Phone counseling intervention |
| Treatment as UsualRoutine HIV clinic-based counseling | Behavioural | Phone counseling intervention, Treatment as Usual |
Primary outcome
Viral load
Time frame: 6 months post-randomization
HIV-1 RNA copies per millilitre of blood plasma
8 secondary outcomes
Medication adherence
Time frame: 6 weeks post-randomization
Mental health (Survey)
Time frame: 6 weeks post-randomization
Medication adherence (Self-reported)
Time frame: 14 weeks post-randomization
Medication adherence (Self-reported)
Time frame: 24 weeks post-randomization
Medication adherence (Self-reported)
Time frame: 36 weeks post-randomization
Mental health (survey)
Time frame: 14 weeks post-randomization
Mental health
Time frame: 24 weeks post-randomization
Mental health
Time frame: 36 weeks post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Background: PubMed 27491288Reynolds NR, Satyanarayana V, Duggal M, Varghese M, Liberti L, Singh P, Ranganathan M, Jeon S, Chandra PS. MAHILA: a protocol for evaluating a nurse-delivered mHealth intervention for women with HIV and psychosocial risk factors in India. BMC Health Serv Res. 2016 Aug 4;16(a):352. doi: 10.1186/s12913-016-1605-1.
- Derived from this study: PubMed 38630259Satyanarayana VA, Duggal M, Jeon S, Singh P, Desai A, Chandra PS, Reynolds NR. Exploring the feasibility, acceptability and preliminary effects of a nurse delivered mhealth intervention for women living with HIV in South India: a pilot randomized controlled trial. Arch Womens Ment Health. 2024 Oct;27(5):751-763. doi: 10.1007/s00737-024-01462-0. Epub 2024 Apr 17.
- Derived from this study: PubMed 32779730Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy R Reynolds, PhD principal investigator
Yale University
Prabha Chandra, MD principal investigator
National Institute of Mental Health and Neuro Sciences (NIMHANS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-delivered mobile phone counseling intervention and Treatment as Usual in people with HIV and Depression, run by Yale University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral load (time frame: 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319330, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.