NCT00860769

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

2.5 years

First QC Date

March 11, 2009

Last Update Submit

September 26, 2016

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (1)

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

    2 years

Study Arms (2)

ASHA Life

EXPERIMENTAL

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

Behavioral: ASHA LIFE

Usual Care

ACTIVE COMPARATOR

3-session educational group focusing on HIV prevention, anti-retroviral therapy (ART) and parenting.

Behavioral: USUAL Care

Interventions

ASHA LIFEBEHAVIORAL

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

ASHA Life
USUAL CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitively impaired, not a participant of Phase 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indian Counsel of Medical Research

New Delhi, India

Location

Related Publications (9)

  • 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.

    PMID: 23539322RESULT

  • 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.

    PMID: 22872107RESULT

  • 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.

    PMID: 22676466RESULT

  • 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.

    PMID: 23370835RESULT

  • 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.

    PMID: 22553317RESULT

  • 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.

    PMID: 21915715RESULT

  • 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.

    PMID: 21692578RESULT

  • 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.

    PMID: 21409663RESULT

  • 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.

    PMID: 21331322RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Adeline Nyamathi, PhD

    The Regents of the University of California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2011

Study Completion

June 1, 2012

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

IN(1)