AzTrials
AzTrials

HIV InfectionsPhase 1/2NCT00860769

Asha HIV Health Promotion Intervention in India

A Phase 1/2 study testing ASHA LIFE in people with HIV Infections, run by University of California, Los Angeles at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this randomized pilot study was to conduct an intervention with 68 rural women living with AIDS to compare the effectiveness of two different programs on compliance with HIV/AIDS treatment regimens, improvement in knowledge about HIV/AIDS and TB, improvement in psychological distress, reduction in… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
ASHA LIFE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteIndia
Study dates
Sep 2008to Jun 2012
Phase
Phase 1/2
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 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women living with HIV
  • Ages 18-45
  • Interfacing with an Accredited Social Health Activist (ASHA)
  • Receiving ART or eligible for receiving ART
  • HIV Positive status
  • CD4 cells ≥ 100
  • Not a participant of Phase 1

Who cannot join

  • Cognitively impaired, not a participant of Phase 1

Trial locations and contacts

1 site in 1 country.

India1 site

  • Indian Counsel of Medical Research

    New Delhi

Other trials in India

About this study

Official title: ASHA HIV Health Promotion Intervention in India

The purpose of this randomized pilot study was to conduct an intervention with 68 rural women living with AIDS to compare the effectiveness of two different programs on compliance with HIV/AIDS treatment regimens, improvement in knowledge about HIV/AIDS and TB, improvement in psychological distress, reduction in stigma; satisfaction with care provided to family members, reduction in number of opportunistic infections, increase in CD4 levels and completion of the designed Asha-Life (AL) program. The trial was designed to assess the impact of the Asha-Life (AL) intervention engaging with an HIV-trained village woman, Asha (Accredited Social Health Activist), to participate in the care of women living with AIDS (WLA), along with other health care providers compared to a Usual Care group. Two high prevalence HIV/AIDS villages in rural Andhra Pradesh, which were demographically alike and served by distinct Public Health Centers, were selected randomly from a total of 16 villages.

Read the detailed description

This Community health study was conducted in two phases:

Phase I was initiated with the establishment of a Community Advisory Board (CAB) composed of 10 persons including WLA, Ashas, and health care providers consisting of Nurse Midwives, HIV and TB experts selected from a Primary Care Clinic in Nellore, Andhra Pradesh. The CAB considered issues related to stigma, disclosure, and psycho-socio-cultural factors affecting the health-seeking behaviors of WLA. They also analyzed the strategies that Asha could employ to support WLA in optimizing their health and well-being and that of their families. This was followed by focus groups conducted separately with the same type of participants. Eligibility criteria included WLA who were currently on ART, were 16-45 years of age, and were able to provide informed consent.

Phase II: A randomized control trial-pilot study was completed in Year 3. We assessed the outcomes of 34 WLA who participated in the AL program at six-month follow-up, as compared with 34 WLA in the Usual Care (UC) Program; in terms of: a) compliance with HIV/AIDS and/or TB treatment regimens (HIV/AIDS/TB), b) improvement in knowledge about HIV/AIDS/TB, c) improvement in psychological distress, d) reduction in stigma, e) reduction in number of opportunistic infections (OIs), f) increase in CD4 levels, and g) completion of the program. The intervention incorporated a comprehensive education and skills program to which we added high protein supplements (1 kg of Black Gram and 1 kg of Toor Dal/month for the AL group vs. a basic program including 1 kg of Channa Dal/month for the UC group.

Conditions
HIV Infections
Being tested
ASHA LIFE, USUAL Care
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASHA LIFEBehavioural

    6-session education groups discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills

  • USUAL CareBehavioural

    3 session educational group focusing on HIV prevention, anti-retroviral therapy and parenting

Study groups in NCT00860769
Study groupRoleWhat they receive
ASHA LifeExperimental6-session educational group discussing HIV prevention, anti-retroviral therapy (ART), coping enhancement, nutrition, parenting and life skills.
Receives: Behavioral: ASHA LIFE
Usual CareActive comparator3-session educational group focusing on HIV prevention, anti-retroviral therapy (ART) and parenting.
Receives: Behavioral: USUAL Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Conduct a randomized clinical pilot study with 70 women living with HIV in India.

    Measured: 2 years

Secondary outcomes (1)

  1. Acceptability of the intervention by the women living with HIV.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2011
  4. Study completionJun 2012

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00860769
Sponsor's protocol ID
G071208102
Other IDs
1 R34 MH082662:01R, 1R34MH082662-01
Status last verified
Sep 2016
First submitted
11 Mar 2009
Last updated
28 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • Nyamathi A, Ekstrand M, Salem BE, Sinha S, Ganguly KK, Leake B. Impact of Asha intervention on stigma among rural Indian women with AIDS. West J Nurs Res. 2013 Aug;35(7):867-83. doi: 10.1177/0193945913482050. Epub 2013 Mar 27.

    PubMed 23539322

  • Nyamathi A, Hanson AY, Salem BE, Sinha S, Ganguly KK, Leake B, Yadav K, Marfisee M. Impact of a rural village women (Asha) intervention on adherence to antiretroviral therapy in southern India. Nurs Res. 2012 Sep-Oct;61(5):353-62. doi: 10.1097/NNR.0b013e31825fe3ef.

    PubMed 22872107

  • Nyamathi A, Salem BE, Meyer V, Ganguly KK, Sinha S, Ramakrishnan P. Impact of an Asha intervention on depressive symptoms among rural women living with AIDS in India: comparison of the Asha-Life and Usual Care program. AIDS Educ Prev. 2012 Jun;24(3):280-93. doi: 10.1521/aeap.2012.24.3.280.

    PubMed 22676466

  • Nyamathi A, Sinha S, Ganguly KK, Ramakrishna P, Suresh P, Carpenter CL. Impact of protein supplementation and care and support on body composition and CD4 count among HIV-infected women living in rural India: results from a randomized pilot clinical trial. AIDS Behav. 2013 Jul;17(6):2011-21. doi: 10.1007/s10461-013-0420-5.

    PubMed 23370835

  • Nyamathi A, Heravian A, Salem B, Suresh P, Sinha S, Ganguly K, Carpenter C, Ramakrishnan P, Marfisee M, Liu Y. Physical and mental health of rural southern Indian women living with AIDS. J Int Assoc Provid AIDS Care. 2013 Nov-Dec;12(6):391-6. doi: 10.1177/1545109712442241. Epub 2012 May 2.

    PubMed 22553317

  • Nyamathi A, Ekstrand M, Zolt-Gilburne J, Ganguly K, Sinha S, Ramakrishnan P, Suresh P, Marfisee M, Leake B. Correlates of stigma among rural Indian women living with HIV/AIDS. AIDS Behav. 2013 Jan;17(1):329-39. doi: 10.1007/s10461-011-0041-9.

    PubMed 21915715

  • Nyamathi A, Heravian A, Zolt-Gilburne J, Sinha S, Ganguly K, Liu E, Ramakrishnan P, Marfisee M, Leake B. Correlates of depression among rural women living with AIDS in Southern India. Issues Ment Health Nurs. 2011;32(6):385-91. doi: 10.3109/01612840.2011.577269.

    PubMed 21692578

  • Nyamathi AM, Sinha S, Ganguly KK, William RR, Heravian A, Ramakrishnan P, Greengold B, Ekstrand M, Rao PV. Challenges experienced by rural women in India living with AIDS and implications for the delivery of HIV/AIDS care. Health Care Women Int. 2011 Apr;32(4):300-13. doi: 10.1080/07399332.2010.536282.

    PubMed 21409663

  • Nyamathi AM, William RR, Ganguly KK, Sinha S, Heravian A, Albarran CR, Thomas A, Greengold B, Ekstrand M, Ramakrishna P, Rao PR. Perceptions of Women Living with AIDS in Rural India Related to the Engagement of HIV-Trained Accredited Social Health Activists for Care and Support. J HIV AIDS Soc Serv. 2010 Oct;9(4):385-404. doi: 10.1080/15381501.2010.525474.

    PubMed 21331322

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ASHA LIFE in people with HIV Infections, run by University of California, Los Angeles 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 7 inclusion and 1 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 28 Sep 2016. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Conduct a randomized clinical pilot study with 70 women living with HIV in India. (time frame: 2 years). 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 NCT00860769, which also lists 9 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 28 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in