Adherence & Retention

Check out Partners In Health's model of treatment accompaniment. Lots of great online resources for those starting a similar model.
http://model.pih.org/community_health_workers/

Dear Colleagues:

3 reported South African data of interest on this topic are summarized in the abstracts below.

In the KwaZulu Natal study by Ghandi et al, the key strategies were to strengthen and adapt preexisting TB DOT infrastrucutre, patient adherence education, training of community health workers (dot supporters and some of whom are HIV positive) and family members to provide support and a once-daily ARV regimen. In this pilot, non-controlled study, the authors reported that the strategy was feasible, effective and safe.

In a pilot qualitative study by our collaborative research group in the periurban townships of Cape Town, South Africa, we also found that a community-based HIV treatment supporters (some where HIV+) was feasible and likely to be effective (JAIDS 2009). However, in a randomized, controlled trial of partial DOT (intervention) compared to standard of care (control), we found that the intervention did not improve adherence (as measured by pill count), or virologic outcomes, but was associated with significantly better 6-month CD4 cell count increases and survival which was not explained by improved virologic or immunologic outcomes. We concluded that further research is needed to examine characteristics of treatment supporters nominated by patients in each condition and ways ...

Dear Colleagues:

3 reported South African data of interest on this topic are summarized in the abstracts below.

In the KwaZulu Natal study by Ghandi et al, the key strategies were to strengthen and adapt preexisting TB DOT infrastrucutre, patient adherence education, training of community health workers (dot supporters and some of whom are HIV positive) and family members to provide support and a once-daily ARV regimen. In this pilot, non-controlled study, the authors reported that the strategy was feasible, effective and safe.

In a pilot qualitative study by our collaborative research group in the periurban townships of Cape Town, South Africa, we also found that a community-based HIV treatment supporters (some where HIV+) was feasible and likely to be effective (JAIDS 2009). However, in a randomized, controlled trial of partial DOT (intervention) compared to standard of care (control), we found that the intervention did not improve adherence (as measured by pill count), or virologic outcomes, but was associated with significantly better 6-month CD4 cell count increases and survival which was not explained by improved virologic or immunologic outcomes. We concluded that further research is needed to examine characteristics of treatment supporters nominated by patients in each condition and ways in which they may or may not have affected patients’ adherence or survival (CROI 2009 Oral Abstract# 143; AIDS 2010, In Press).

Best Wishes,

Jean

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JAIDS 2009 Jan 1;50(1):37-43.


Successful integration of tuberculosis and HIV treatment in rural South Africa: the Sizonq'oba study.
Gandhi NR, Moll AP, Lalloo U, Pawinski R, Zeller K, Moodley P, Meyer E, Friedland G; Tugela Ferry Care and Research (TFCaRes) Collaboration.
Yale University School of Medicine, New Haven, CT, USA.

BACKGROUND: Tuberculosis (TB) is the leading cause of death among HIV-infected patients worldwide. In KwaZulu-Natal, South Africa, 80% of TB patients are HIV coinfected, with high treatment default and mortality rates. Integrating TB and HIV care may be an effective strategy for improving outcomes for both diseases. METHODS: Prospective operational research study treating TB/HIV-coinfected patients in rural KwaZulu-Natal with once-daily antiretroviral (ARV) therapy concurrently with TB therapy by home-based, modified directly observed therapy. Patients were followed for 12 months after ARV initiation. RESULTS: Of 119 TB/HIV-coinfected patients enrolled, 67 (56%) were female, mean age was 34.0 years, and median CD4 count was 78.5 cells per cubic millimeter. After 12 months on ARVs, mean CD4 count increase was 211 cells per cubic millimeter, and 88% had an undetectable viral load; 84% completed TB treatment. Thirteen patients (11%) died; 10 (77%) with multidrug-resistant or ext
ensively drug-resistant TB. There were few severe adverse events or immune reconstitution events. Adherence was high with 93% of study visits attended and 99% of ARV doses taken. CONCLUSIONS: Integration of TB and HIV treatment in a rural setting using concurrent home-based therapy resulted in excellent adherence and TB and HIV outcomes. This model may result in successful management of both diseases in other rural resource-poor settings.

PMID: 19295333

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J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S127-33.

Treatment supporter to improve adherence to antiretroviral therapy in HIV-infected South African adults. A qualitative study.
Nachega JB, Knowlton AR, Deluca A, Schoeman JH, Watkinson L, Efron A, Chaisson RE, Maartens G.
Department of International Health, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland 21215, USA.

Little is known about the patient characteristics, social support networks, and relationship factors associated with excellent adherence in resource-limited settings, even though these can be important clues that inform the identification of targets and the approaches of individual- and community-based antiretroviral therapy adherence interventions. In this study, we aimed to understand how patient-selected treatment supports might affect antiretroviral treatment outcomes and to identify key components of support, including the social and material resources necessary for promoting high adherence in South Africa. Data were collected from the proceedings of 2 focus groups with 6 HIV-infected adults each and from 7 in-depth interviews with health care providers in the Western Cape Province of South Africa. The patients and health care workers identified individuals-usually a mother, daughter, sister, brother, or partner-who were confidantes and had moral authority with them. The
se individuals command respect, and patients allow them to influence health-related decision making, both of which are necessary if they are to be effective treatment supporters. Barriers to adherence identified by study participants include alcohol abuse, stigma related to disclosure of HIV status, and lack of financial resources and food. These are critically important challenges to address if high adherence is to be achieved in this setting. In addition, our results suggest that interventions tailored to treatment supporter characteristics and relationship factors may be effective in influencing patients' antiretroviral therapy adherence.


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CROI 2009 Oral Abstract #143
Randomized Trial of Trained Patient-nominated Treatment Supporters Providing Partial Directly Observed ART in South African Adults Initiating HIV Therapy
Jean Nachega*1,2, R Goliath2, A Efron1, M Chaudhary1, M Ram1, C Morroni2, H Schoeman2, R Chaisson1, and G Maartens2
1Johns Hopkins Univ, Baltimore, MD, US and 2Univ of Cape Town, South Africa


Background: Directly observed therapy (DOT) of ART in Sub-Saharan Africa has been suggested to improve adherence. We conducted a randomized trial in an ART roll-out clinic at GF Jooste Hospital in Cape Town, South Africa, to determine the effect of trained patient-nominated treatment supporters providing partial DOT on outcomes of ART.
Methods: Adult patients initiating ART (stavudine/lamivudine/efavirenz [d4T/3TC/EFV] or nevirapine [NVP]) nominated treatment supporters and were randomized to DOT-ART intervention arm, with baseline and follow-up training in adherence and social support for treatment supporters who provided partial DOT for 12 months observing at least 1 daily dose, or control arm (self-administered ART, and only baseline training of treatment supporters). The primary endpoints were proportion with undetectable HIV viral load and change in CD4 counts at 12 and 24 months.
Results: We enrolled 274 patients, of whom 222 reached the 12-month endpoint. The Data and Safety Monitoring Board (DSMB) stopped the study early because of its futility, based on interim CD4 and viral load outcomes. The mean age was 36 years, 42% were male, 46% had WHO Stage 4 disease and median baseline CD4 counts and viral load were 92 and log 4.96 (DOT-ART) and 99 and log 4.98 (control). The baseline characteristics of the DOT-ART and control arms were similar. In the intention-to-treat analysis (missing = failure), the proportion of patients with detectable viral load at 12 and 24 months was 35.3% and 50.7% in the DOT-ART arm vs 37.5% and 52.2% in the control group (p = 0.71 and p = 0.81 respectively). The mean change in CD4 lymphocyte count at 12 months was 211 (DOT-ART) and 173 (control; p = 0.06), and at 24 months 291 and 273 (p = 0.55). In an as-treated analysis, percentage with undetectable viral load at 12 months were 20% and 18% for DOT-ART and control, respective
ly. Baseline predictors of virologic success at 12 months in a multivariate analysis were female sex (OR 0.46, 95%CI 0.22 to 0.96) and age >35 years (OR 0.47, 95%CI 0.22 to 0.93). Survival was significantly better in the DOT-ART arm: 9 deaths of 137 (7%) vs 19 of 137 (14%) in the control arm (p = 0.05).
Conclusions: DOT-ART did not improve virologic and CD4 outcomes in this controlled trial. Virologic outcomes were excellent in those who continued therapy, but the 1-year 35% virologic failure rate indicates that additional interventions to improve outcomes are necessary. The survival advantage of DOT-ART requires further investigation.
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Thanks Maria for posting my questions here.

Currently, we're running a community-based DR-TB program at the Indus Hospital in Karachi, Pakistan. The model replicates the Peru program in terms of structure (clinical support, social support, and community-based DOT).

At this stage, we're looking to introduce (and assess the impact of) a "buddy system." This system would use patients who have either completed the 24 month treatment or are towards the end of their treatment to provide support to those who are just starting treatment. This role would be different from that of treatment supporters (providing DOT and reporting adverse events). Instead, it would be more of emotional support---a person that patients can speak to and draw strength from their own experiences (sort of like sponsors in Alcoholics Anonymous).

Does anyone know of any such programs that we can look at in developing our model? It may even be useful to see programs that use 'buddies' for DOTin which the criteria is that one has to be a former/existing patient. We're heard that this is being used in Peru by Socios En Salud at the moment but I haven't been able to find more details on ...