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Patients on antiretroviral therapy who were lost to follow-up at a tertiary care hospital, Pune, India.

INTRODUCTION: The finest outcome of antiretroviral therapy can be achieved only with unabridged compliance. In Maharashtra state of India, there are 58 ART centers. ART center B.J. medical college and Sassoon general hospital, Pune was established in 2005. Since then more than 27,000 patients have been registered in HIV care and more than 14,000 patients are presently benefitting from ART. Far fewer people are progressing to AIDS, and the age-adjusted death rate from HIV/AIDS has declined conspicuously. Adherence to ART has emerged as the major determinant in this success.

Non-adherence and incomplete adherence culminates in virological failure, which diminishes the potential for long-term clinical success. Drug-resistant strains of HIV selected through ongoing replication in the presence of ART also can be transmitted to uninfected or drug-naive patients, leaving them with fewer treatment options, ultimately increasing the mortality. (1) Adherence is not the only determinant of ART failure or success. Other factors include genetic differences in drug metabolism, severe baseline immune suppression, prior drug resistance, and concurrent opportunistic infections. Adherence to ART, however, is one of few potentially alterable factors determining outcomes for patients with HIV.

This article throws light on various factors having impact on antiretroviral adherence, with a focus on practical strategies for assessing and improving adherence.

OBJECTIVES: To understand the reasons why patients defaulted from antiretroviral treatment (ART) program so as to help design interventions that improve treatment retention and ultimately, patient outcomes.

MATERIALS AND METHODS: This is a retrospective study conducted at ART Centre B.J. Medical College and Sassoon General Hospital Pune, between January 2012 and September 2012. The study was conducted with permission from the Ethical Committee, BJMC, Pune.

INCLUSION CRITERIA: Patients lost to follow up and who restarted ART at our Center.

DEFINITION OF LFU: LFU has been divided into Pre ART and On ART LFU.

PRE--ART LFU: As per the definition of Pre-ART LFU, all those patients under Pre ART care who have been termed as LFU and whose last visit was before more than one year.

ON ART LFU: A patient will be termed as LFU only if he/she does not turn up any time during the entire month after three months during which the appointment was scheduled.

This study is qualitative and focuses on socio-economic status, reason for LFU and why they returned to re-enter in ART program. We attempt to bring to light reasons behind getting lost to follow-up.

DATA COLLECTION PROCEDURE: All LFU patients interviewed during restart the ART, in ART center BJMC Pune.

DEFINITION KEYS AND TERMS:

LFU: lost to follow up

ART: Anti-Retro viral Therapy

BJMC: Byramjee Jeejeebhoy Medical College

SGH: Sassoon General Hospitals

Pvt.: Private

01: Opportunistic infection

ORW: Out-reach worker

RESULTS: Out of a total 51 study patients, 11 patients were illiterate. Patients educated to a primary level constituted the maximum number of LFU [21(41.18%)], whereas only 5(9.80%) patients were educated beyond secondary school & college, all being male. Illiteracy rate was high in age group above 35 years and in females as compared to males. None of the females was educated above primary level.

Maximum number of patients were driver by occupation [14(27.45%)] with a male predominance. Patients from labour class were 13(25.49%), out of which 8(15.69%) were male and 5(9.80%) were female. Only 3(5.88%) patients had income above Rs.10, 000/per month. 22(43.14%) patient's had income between Rs.2001-5000 out of which 15(29.41%) were male and 7(13.73%) were female. The rest had income below Rs.2000/month. Maximum females [8(15.69%)] had income below 2000.The maximum number of earning people were above 35 years of age. Most of the patients belonged to income group of Rs.2, 001-5,000/per month. 19 (37.25%) patients were from low income group i.e. below Rs.2000/per month.

[FIGURE 1 OMITTED]

Out of 51 patients, 24(47.06%) patients were married (19 male and 5females), 7(13.73%) males and 7(13.73%) females were widowed, 7(13.73%) patients were single (unmarried) and 6 patients were separated/ divorced. Most of the widowed patients were above 35 years age group.

[FIGURE 2 OMITTED]

Out of 24(47.06%) married patients, 12(50%) male patients were discordant and 1(4%) female was discordant

Remaining 11(46%) patients were non-discordant Maximum numbers of patients (26) were living within 20 km distance from ART Centre. Only 13(25.49%) patients were living beyond 100 km from ART Centre.

Migration was the cause of LFU in 13(25.49%). 8(15.69%).Death of a family member was the cause for LFU in 8 cases and 6(11.76%) patients were LFU because of medication related side effects. Family disturbances led to defaulting in 5 (9.80%) and in another 5(9.80%) due to other treatment like alternative medicine. Only male patients resorted to alternative medicine. Psychiatric problems were noted in three cases. Migration was the commonest reason for LFU 13(25.69%) patients and maximum numbers of migrants were above 35 years of age.

Patients who restarted ART after having opportunistic infection were 10(19.61%). Generalized weakness, oral infection, Diarrhea and indoor (hospitalized) patients were observed in 17(33.33%), 1(1.96%), 2(3.92%) and 1(1.96%) respectively. Remaining 20(39.22%) patients were asymptomatic. A significant number of patients were alcoholic and all were male and 18(35.29%) patients were above 35 years of age. Patients who were LFU within 0-1 month were 9(17.65%), within 1-3 months were 14(27.45%), within 4-6 months were 8(15.69%), within 7-12 months were 6(11.76%) and 14(27.45%) patients were LFU after more than one year from initiation of ART.

Patients restarted ART because they returned back to home (10), had weakness (7) or had some opportunistic infection (5). Only 4(7.84%) patients restarted ART in response to phone calls by health care worker and 3 (5.88%) upon doctor's advice. Two patients restarted ART after home visit by Out-reach worker.

[FIGURE 3 OMITTED]

DISCUSSION: We collected data of fifty one HIV sero-positive patients who were started on ART, who subsequently lost to follow-up and who restarted ART between January 2012 and September 2012. Male LFUs significantly out-numbered females by a double1. This could probably be explained by the fact that males were from working class and so had an easy access to the ART center as compared to females who were predominantly housewives had limited access to the services provided by the ART center.

Non-adherence was high in patients more than 35 years of age and least in teenagers. (2) The majority of patients belonging to age group more than 35 years was from a working class and had migrated for work reasons came back to their original place of work and hence restarted the ART. Drivers and manual laborers were a sizeable number of LFUs. Both these groups were migratory population and gave history of frequent change of workplace and they could take ART medications only when they returned home. Illiteracy contributed to a significant no. of LFU and a greater proportion of these were females. (3)

Majority of the patients belonged to a low income class (earning below Rs.5000/month). These patients, who were on daily wages, preferred to remain absent on scheduled visit to the ART center. As far as the distance from the ART center is concerned, most of them lived within 20 kilometer area and only 25% patients lived beyond 100 kilometers (4). There were 24 (47.06%) patients who were married and out of these 12 male patients were discordant, while only one female was discordant. The spouses of these patients being not HIV infected, the compliance was seriously affected and their turn-out to the ART center was less as compared to those couples in which both the spouses were HIV infected.

The reasons why our patients who were LFU are of great importance as they are different for every center and knowing these will help us to modify our policies to prevent more LFUs. (5,6) In this study, migration was the most common reason as about 25.6 % patients who restarted ART were from labour class and had frequent change of place either within the state or outside the state. The next common cause was death of a family member. This factor was important in females as they could not attend the center on the day scheduled.

Family disturbances like stress, marital disharmony and illness related depression were seen only in the males and more so in discordant couples (7,8).

Drug related adverse effects caused about 11.76% patients to discontinue ART and in other studies this was one of the most common reasons for LFU. Alternative treatment like Ayurvedic, Homeopathic, Unani, naturopathy and similar modalities were resorted to by about 9.80% patients. Once there was no response to these forms of treatment or there was deterioration in the physical health, these patients came back to the ART center for restarting ART (9).

The condition of the patient while restarting the treatment was assessed and we found that most had generalized weakness (33.3%) and 19.6% patients had some or the other opportunistic infection. (10) More than 50% of the patients had worsening of their disease. Alcoholism was observed in 45% of patients, exclusively in males and majority was above 35 years of age (8). The duration of LFU from initiation of treatment was either less than 3 months or more than a year. This shows that the first three months of initiation of ART are crucial in maintaining good adherence (12).

When we questioned about the reason why they came back to the ART center, maximum number of patients stated that they had come to Pune for work and so had enrolled themselves here. After going to the native place, these patients did not transfer out and had no medicines during that period. They returned back to Pune for various reasons. The next common reason for restarting ART was generalized weakness and debility and this group of patients believed that their symptoms would resolve after restarting ART. Similar number of patients restarted due to opportunistic infections. (13)

All the LFU patients were contacted by telephone by the counselors, but communication was established only with 30% of the patients. Out of these, only 7.8 % responded positively and were able to start ART again. Thus, many patients could not be traced due to incorrect phone numbers and address given by them. We therefore need to improve upon the data recording and patient tracking system. (14)

Conclusion:

Our study brings to light the various reasons for non-compliance and non-adherence to ART. Migration being a very important issue, special care needs to be taken in maintaining records of these patients. Alcoholism remains an important social stigma and further aggravates non-adherence. Motivation for alcohol abstinence and prompt referral to de-addiction center is essential. Incidence of being lost to follow-up is high in discordant couples. Generalized weakness, opportunistic infections and return to the native place were the eminent features noted in patients who returned back to restart antiretroviral therapy.

DOI:10.14260/jemds/2014/3337

REFERENCES:

(1.) Amuron B, Levin J, Birunghi J, et al. Mortality in an antiretroviral therapy programme in Jinja, south-east Uganda: a prospective cohort study. AIDS Res Ther. 2011; 8: 39.

(2.) Ochieng-Ooko V, Ochieng D, Sidle JE, et al. Influence of gender on loss to follow-up in a large HIV treatment programme in western Kenya. Bull World Health Organ 2010; 88(9): 681-688.

(3.) Brinkhof MW, Pujades-Rodriguez M, Egger M. Mortality of patients lost to follow-up in antiretroviral treatment programmes in resource-limited settings: systematic review and metaanalysis. PLoS One. 2009; 4(6): e5790.

(4.) Harries AD, Zachariah R, Lawn SD, Rosen S. Strategies to improve patient retention on antiretroviral therapy in sub-Saharan Africa. Trop Med Int Health 2010; 15 Suppl 1: 70-75.

(5.) Pecoraro A, Royer-Malvestuto C, Rosenwasser B, et al. Factors contributing to dropping out from and returning to HIV treatment in an inner city primary care HIV clinic in the United States. AIDS care. 2013; 25(11): 1399-1406.

(6.) Tassie JM, Baijal P, Vitoria MA, Alisalad A, Crowley SP, Souteyrand Y. Trends in retention on antiretroviral therapy in national programs in low-income and middle-income countries. J Acquir Immune Defic Syndr 2010; 54(4): 437-441

(7.) Geng EH, Bangsberg DR, Musinguzi N, et al. Understanding reasons for and outcomes of patients lost to follow-up in antiretroviral therapy programs in Africa through a sampling-based approach. J Acquir Immune Defic Syndr 2010; 53(3): 405-411.

(8.) Madras BK, Compton WM, Avula D, Stegbauer T, Stein JB, Clark HW. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend 2009; 99 (1-3): 280-295.

(9.) Miller CM, Ketlhapile M, Rybasack-Smith H, Rosen S. Why are antiretroviral treatment patients lost to follow-up? A qualitative study from South Africa. Trop Med Int Health 2010;15 Suppl 1: 48-54.

(10.) Nachega JB, Mills EJ, Schechter M. Antiretroviral therapy adherence and retention in care in middle-income and low-income countries: current status of knowledge and research priorities. Curr OpinHIV AIDS 2010; 5(1): 70-77.

(11.) Boyer S, March L, Kouanfack C, et al. Monitoring of HIV viral load, CD4 cell count, and clinical assessment versus clinical monitoring alone for antiretroviral therapy in low-resource settings (Stratall ANRS 12110/ESTHER): a cost-effectiveness analysis. Lancet Infect Dis2013; 13(7): 577-586.

(12.) Geng EH, Nash D, Kambugu A, et al. Retention in care among HIV-infected patients in resourcelimited settings: emerging insights and new directions. Curr HIV/AIDS Rep 2010; 7(4): 234244.

(13.) Gross R, Bellamy SL, Chapman J, et al. Managed problem solving for antiretroviral therapy adherence: a randomized trial. JAMA Intern Med 2013; 173(4): 300-306.

(14.) Yu JK, Chen SC, Wang KY, et al. True outcomes for patients on antiretroviral therapy who are "lost to follow-up" in Malawi. Bull World Health Organ 2007; 85(7): 550-554.

Dileep B. Kadam [1], Sonali P. Salvi [2], Suryakan Mane [3]

AUTHORS:

[1.] Dileep B. Kadam

[2.] Sonali P. Salvi

[3.] Suryakan Mane.

PARTICULARS OF CONTRIBUTORS:

[1.] Professor and Head, Department Of Internal Medicine, B.J. Government Medical College and Sassoon General Hospitals, Pune (Maharashtra), India.

[2.] Assistant Professor, Department Of Internal Medicine, B.J. Government Medical College and Sassoon General Hospitals, Pune (Maharashtra), India.

[3.] Counsellor, Anti-Retroviral Therapy Centre, B.J. Government Medical College and Sassoon General Hospitals, Pune (Maharashtra), India.

NAME ADDRESS EMAIL ID OF THE CORRESPONDING AUTHOR:

Dr. Sonali P. Salvi, 228/2A, Behind Ashok Theatre, Pimpri, Pune.

Email: sonalionly@gmail.com

Date of Submission: 20/08/2014.

Date of Peer Review: 21/08/2014.

Date of Acceptance: 30/08/2014.

Date of Publishing: 03/09/2014.
Table 1. Patient Characteristics and Socio-Demographic
Features of Lost To Follow Up Cases No. (%)

                                       Age

                          0-14 yrs.           15-25 yrs

Education
Illiterate                    0            [02.sub.(3.92)]
Primary                [2.sub.(3.92)]      [01.sub.(1.96)]
Secondary School              0             [00.sub.(0)]
College and above             0             [00.sub.(0)]
Total                  [2.sub.(3.92)]      [3.sub.(5.88)]

Income                     0-2000          [01.sub.(1.96)]
                          2001-5000        [01.sub.(1.96)]
                         5001-10000         [00.sub.(0)]
                         Above 10000        [00.sub.(0)]
                            Total          [02.sub.(3.92)]

Family status              Single          [02.sub.(3.92)]
                           Married          [00.sub.(0)]
                      Separated/divorce     [00.sub.(0)]
                           Widowed          [00.sub.(0)]
                            Total          [02.sub.(3.92)]

Distance                   0-20 km          [00.sub.(0)]
                          21-50 km          [00.sub.(0)]
                          51-100 km         [00.sub.(0)]
                        Beyond 100 km      [02.sub.(3.92)]
                            Total          [02.sub.(3.92)]

Alcohol                      Yes            [00.sub.(00)]
                             No            [02.sub.(3.92)]
                            Total          [02.sub.(3.92)]
Reason for LFU       Psychiatric problem    [00.sub.(0)]
                     Family disturbances    [00.sub.(0)]
                       Death in family      [00.sub.(0)]
                           Illness          [00.sub.(0)]
                       Other treatment      [00.sub.(0)]
                     Adverse drug effect   [01.sub.(1.96)]
                          Migration         [00.sub.(0)]
                           Others          [01.sub.(1.96)]
                            Total          [02.sub.(3.92)]
                     Psychiatric problem    [00.sub.(0)]
                     Family disturbances    [00.sub.(0)]

                                     Age

                        26-35 yrs           Above 35

Education
Illiterate           [02.sub.(3.92)]    [07.sub.(13.73)]
Primary              [09.sub.(17.65)]   [09.sub.(17.65)]
Secondary School     [01.sub.(1.96)]    [12.sub.(23.53)]
College and above    [01.sub.(1.96)]     [05.sub.(9.80)]
Total                [13.sub.(25.49)]   [33.sub.(64.71)]

Income               [01.sub.(1.96)]     [05.sub.(9.80)]
                     [02.sub.(3.92)]     [05.sub.(9.80)]
                       [00.sub.(0)]      [02.sub.(3.92)]
                       [00.sub.(0)]      [01.sub.(1.96)]
                     [03.sub.(5.88)]     13.sub.(25.49)]

Family status        [01.sub.(1.96)]     [01.sub.(1.96)]
                     [01.sub.(1.96)]     [05.sub.(9.80)]
                     [01.sub.(1.96)]     [03.sub.(5.88)]
                       [00.sub.(0)]      [04.sub.(7.84)]
                     [03.sub.(5.88)]     13.sub.(25.49)]

Distance             [02.sub.(3.92)]     [05.sub.(9.80)]
                       [00.sub.(0)]      [01.sub.(1.96)]
                     [01.sub.(1.96)]     [03.sub.(5.88)]
                       [00.sub.(0)]      [04.sub.(7.84)]
                     [03.sub.(5.88)]     13.sub.(25.49)]

Alcohol              [01.sub.(1.96)]     [04.sub.(7.84)]
                     [03.sub.(5.88)]    [08.sub.([15.69)]
                     [04.sub.(7.84)]    [12.sub.(23.53)]
Reason for LFU         [00.sub.(0)]       [00.sub.(0)]
                       [00.sub.(0)]      [01.sub.(1.96)]
                       [00.sub.(0)]      [02.sub.(3.92)]
                       [00.sub.(0)]      [01.sub.(1.96)]
                       [00.sub.(0)]      [01.sub.(1.96)]
                     [02.sub.(3.92)]     [01.sub.(1.96)]
                     [01.sub.(1.96)]     [03.sub.(5.88)]
                       [00.sub.(0)]      [04.sub.(7.84)]
                     [03.sub.(5.88)]     13.sub.(25.49)]
                       [00.sub.(0)]       [00.sub.(0)]
                       [00.sub.(0)]      [01.sub.(1.96)]

                                    Gender

                           Male                Female

Education
Illiterate            [05.sub.(9.80)]     [06.sub.(11.76)]
Primary              [11.sub.(21.56)]     [10.sub.(19.61)]
Secondary School     [13.sub.(25.49)]     [00.sub.(0.00)]
College and above    [06.sub.(11.76)]     [00.sub.(0.00)]
Total                [35.sub.(68.62)]     [16.sub.(31.37)]

Income               [12.sub.(23.53)]     [11.sub.(21.57)]
                     [14.sub.(27.45)]     [15.sub.(29.41)]
                      [05.sub.(9.80)]     [06.sub.(11.76)]
                      [02.sub.(3.92)]     [03.sub.(5.88)]
                     [33.sub.(64.71)]     [35.sub.(68.63)]

Family status         [03.sub.(5.88)]     [05.sub.(9.80)]
                     [18.sub.([35.29)]    [19.sub.(37.25)]
                      [02.sub.(3.92)]     [04.sub.(7.84)]
                     [10.sub.([19.61)]    [07.sub.(13.73)]
                     [33.sub.(64.71)]     [35.sub.(68.63)]

Distance             [19.sub.(37.25)]    [18.sub.([35.[19)]
                      [05.sub.(9.80)]     [05.sub.(9.80)]
                      [02.sub.(3.92)]     [04.sub.(7.84)]
                     [07.sub.(13.73)]    [08.sub.([15.69)]
                     [33.sub.(64.71)]     [35.sub.(68.63)]

Alcohol              [18.sub.([35.29)]   [23.sub.(45.[10)]
                     [15.sub.(29.41)]     [12.sub.(23.53)]
                     [33.sub.(64.71)]     [35.sub.(68.63)]
Reason for LFU        [03.sub.(5.88)]     [02.sub.(3.92)]
                      [05.sub.(9.80)]     [06.sub.(11.76)]
                     [06.sub.(11.76)]     [02.sub.(3.92)]
                       [00.sub.(0)]         [00.sub.(0)]
                      [04.sub.(7.84)]     [05.sub.(9.80)]
                      [02.sub.(3.92)]     [05.sub.(9.80)]
                      09.sub.(17.65)]     09.sub.(17.65)]
                      [04.sub.(7.84)]     [06.sub.(11.76)]
                     [33.sub.(64.71)]     [35.sub.(68.63)]
                      [03.sub.(5.88)]     [02.sub.(3.92)]
                      [05.sub.(9.80)]     [06.sub.(11.76)]

Table 2

                                               Male

Duration
of ART                0-1 month          [7.sub.(13.73)]
                     1-3 months          [8.sub.(15.69)]
                     4-6 months           [5.sub.(9.8)]
                     7-12 months          [4.sub.(7.84)]
                  More than 1 year       [11.sub.(21.57)]

Condition of
patient at
restart

                      Weakness           [12.sub.(23.53)]
                    Asymptomatic         [12.sub.(23.53)]
                    Tuberculosis         [8.sub.(15.69)]
                   Oral infection         [1.sub.(1.96)]
                      Diarrhea            [1.sub.(1.96)]
                     In-patient           [1.sub.(1.96)]

Why they
Restarted?

                      Weakness           [7.sub.(13.73)]
               Family dispute resolved    [3.sub.(5.88)]
                  Return back home       [6.sub.(11.76)]
                   No response to         [4.sub.(7.84)]
                Alternative treatment
                 Return after family      [1.sub.(1.96)]
                   member's death
               Opportunistic infection    [5.sub.(9.80)]
                   Phone call from        [3.sub.(5.88)]
                     ART Centre
                  Home visit by ORW       [2.sub.(3.92)]
                   Doctor's advice        [2.sub.(3.92)]
                       Others             [2.sub.(3.92)]

                                              Female

Duration
of ART                0-1 month           [2.sub.(3.92)]
                     1-3 months          [6.sub.(11.76)]
                     4-6 months           [3.sub.(5.88)]
                     7-12 months          [2.sub.(3.92)]
                  More than 1 year        [3.sub.(5.88)]

Condition of
patient at
restart

                      Weakness            [5.sub.(9.80)]
                    Asymptomatic         [8.sub.(15.69)]
                    Tuberculosis          [2.sub.(3.92)]
                   Oral infection          [0.sub.(0)]
                      Diarrhea            [1.sub.(1.96)]
                     In-patient            [0.sub.(0)]

Why they
Restarted?

                      Weakness            [1.sub.(1.96)]
               Family dispute resolved    [1.sub.(1.96)]
                  Return back home        [4.sub.(7.84)]
                   No response to          [0.sub.(0)]
                Alternative treatment
                 Return after family      [5.sub.(9.80)]
                   member's death
               Opportunistic infection    [1.sub.(1.96)]
                   Phone call from        [1.sub.(1.96)]
                     ART Centre
                  Home visit by ORW        [0.sub.(0)]
                   Doctor's advice        [1.sub.(1.96)]
                       Others             [2.sub.(3.92)]

                                              TOTAL

Duration
of ART                0-1 month          [9.sub.(17.65)]
                     1-3 months          [14.sub.(27.45)]
                     4-6 months          [8.sub.(15.69)]
                     7-12 months         [6.sub.(11.76)]
                  More than 1 year       [14.sub.(27.45)]

Condition of
patient at
restart

                      Weakness           [17.sub.(33.33)]
                    Asymptomatic         [20.sub.(39.22)]
                    Tuberculosis         [10.sub.(19.61)]
                   Oral infection         [1.sub.(1.96)]
                      Diarrhea            [2.sub.(3.92)]
                     In-patient           [1.sub.(1.96)]

Why they
Restarted?

                      Weakness           [8.sub.(15.69)]
               Family dispute resolved    [4.sub.(7.84)]
                  Return back home       [10.sub.(19.61)]
                   No response to         [4.sub.(7.84)]
                Alternative treatment
                 Return after family     [6.sub.(11.76)]
                   member's death
               Opportunistic infection   [6.sub.(11.76)]
                   Phone call from        [4.sub.(7.84)]
                     ART Centre
                  Home visit by ORW       [2.sub.(3.92)]
                   Doctor's advice        [3.sub.(5.88)]
                       Others             [4.sub.(7.84)]
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Title Annotation:ORIGINAL ARTICLE
Author:Kadam, Dileep B.; Salvi, Sonali P.; Mane, Suryakan
Publication:Journal of Evolution of Medical and Dental Sciences
Geographic Code:9INDI
Date:Sep 4, 2014
Words:3703
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