Translate Sign in JOIN

Adherence & Retention

Directly observed antiretroviral therapy: a systematic review and meta-analysis of randomised clinical trials

Started by Jean Nachega, MD, PhD on 26 Dec 2009

Dear Colleagues:

In the Volume 374, Issue 9707, 19 December 2009 Issue of the Lancet, Ford and colleagues did report the results of a systematic review and meta-analysis of directly observerd antiretroviral therapy showing that this strategy did offer no benefit over self-administered treatment. These findings calls into question the use of such approach to support cART adherence in the general patient population. The abstract can be find via the following weblink or further below:

www.thelancet.com/journals/lancet/article/PIIS0140673609616718/abstract?rss=yes
 

In addition, we are inviting GHD Adherence and Retention members to comment on their experiences and/or these study results.

JN
-----------------------------------------------

Background
----------
Directly observed therapy has been recommended to improve adherence for patients with HIV infection who are on highly active antiretroviral therapy, but the benefit and cost-effectiveness of this approach has not been established conclusively. We did a systematic review and meta-analysis of randomised trials of directly observed versus self-administered antiretroviral treatment.

Methods
--------
We did duplicate searches of databases (from inception to July 27, 2009), searchable websites of major HIV conferences (up to July, 2009), and lay publications and websites (March—July, 2009) to identify randomised trials assessing directly observed therapy to promote adherence to antiretroviral therapy in adults. Our primary outcome was virological suppression at study completion. We calculated relative risks (95% CIs), and pooled estimates using a random-effects method.

Findings
--------
12 studies met our inclusion criteria; four of these were done in groups that were judged to be at high risk of poor adherence (drug users and homeless people). Ten studies reported on the primary outcome (n=1862 participants); we calculated a pooled relative risk of 1·04 (95% CI 0·91—1·20, p=0·55), and noted moderate heterogeneity between the studies (I2= 53·8%, 95% CI 0—75·7, p=0·0247) for directly observed versus self-administered treatment.

Interpretation
---------------
Directly observed antiretroviral therapy seems to offer no benefit over self-administered treatment, which calls into question the use of such an approach to support adherence in the general patient population.

Replies (13) Add reply
1

Ann Deschamps

Dear Jean,

I'm not surprised about the results. To my opinion DOT is usefull in highly nonadherent patients who lack a structure in their lives which they can use to guide their medication intake. Using DOT in the whole HIV population is expensive and not feasible.

Ann Deschamps

3:58 AM, 28 Dec 2009 | Permalink

2

Jean Nachega, MD, PhD

Thanks Ann. I agree with your comment. For clinical/public health practice, it is important that we have now hard data from both developed & developing countries which sheds lights on this controversial issue in support of earlier expert opinions.
Best Wishes for the New Year!
Jean

4:57 AM, 28 Dec 2009 | Permalink

3

K. Rivet Amico, PhD

Ann's comments here are really important. While we are all interested in finding a strategy that works, finding one that works for everyone equally well may be an oversimplification. What works, for whom, when is likely the better question. We need the meta work and the large trials to provide empirical guidance. Research of this kind helps to answer- What is likely or unlikely to work well, globally (in general and in comparison to something). We have far less guidance on how the intervention worked for what types of people with what kinds of challenges. It is critical that we NOT lose the point that no behavioral intervention is likely to work for everyone. Personally, I look forward to advances in research on efficacy analyses or efficacy subset analyses, in RCTs or demonstration trials, as one way to start generating answers to 'what seems to work best for whom when'. The other thing to keep in mind is that the intervention trials formally evaluated are always in comparison to something. Recent meta work by deBruin et al. suggest that there are many active ingredients in the comparison groups (control arms) used in ARV adherence intervention trials- multiple strategies levied ...

expand comment

8:30 AM, 28 Dec 2009 | Permalink

4

Ann Deschamps

Dear Rivet, dear Jean,

wouldn't this be a topic for a workshop at the next IAPAC NIMH conference?
Ann Deschamps

7:11 AM, 30 Dec 2009 | Permalink

5

Jean Nachega, MD, PhD

Dear Ann:
Certainly! A workshop at the 5th NIH/NIMH-IAPAC International HIV Treatment Adherence Meeting (Miami, May 23-25, 2010) seems an ideal opportunity. I will make the suggestion to my colleagues on the Program Committee. While providing important and useful information, the recent Lancet paper (Ford et al. 2009) is not the final answer to all questions related to this debate. In meantime, we continue to encourage reactions of GHD members for a healthy and instructive debate.
Best, Jean

11:49 AM, 30 Dec 2009 | Permalink

6

Ann Deschamps

Dear all

in reply of Rivet's comments (what really works for whom and when) I suggest that we focus a workshop on connecting the needs of the practice with the knowledge of the research. Mostly, we do a review, find the ‘gap’ in research and design a study, without considering the lived experience in the clinical field.
I'm now doing research on diabetes type 2 management (call it adherence, self management, it all comes to the same thing: helping patients to deal with their disease, their health and optimize their clinical outcome and quality of life).
We hypothesized that the implementation of e-communication would improve the care for and the communication with the patients and the health care workers.
We first started with going to the literature, and there is already some evidence that supports this. Then we started talking with key persons in the clinical field and discovered that very recently the government changed the organization of the care for diabetes patients into a 'care path' with a central role for the general physician, the patient, the specialized doctor in endocrinology, the community nurse and nutritionists who educate the patient. All those partners work with different ICT ...

expand comment

8:48 AM, 26 Jan 2010 | Permalink

7

Marijn de Bruin

Dear all,

I just became member of this website because I saw this communication about adherence support in relation to HIV (and learning from other fields such as Diabetes). I am the de Bruin et al. person Rivet refered to. Rivet and I have had contact about our work and future plans a couple of times, following from our meta-analyses.

Below the abstracts of 2 meta-analyses I recently published on these topics (last one this monday), which may be interesting in relation to this discussion.

Best wishes,
Marijn de Bruin

http://psycnet.apa.org/index.cfm?fa=buy.optionToBuy&id=2009-20990-003&CFID=60...

http://archinte.ama-assn.org/cgi/content/short/170/3/240?rss=1

8:52 AM, 12 Feb 2010 | Permalink

8

Jean Nachega, MD, PhD

Dear Marijn:

Welcome to GHD!

Are you planning to attend the 5th NIMH-IAPAC International HIV Adherence Meeting to be held in Miami (May 23-25)? If yes, it will be great to see you there. We did submit a workshop proposal to discuss the current evidences related to the effectiveness of directly observed therapy in different settings, share experiences/perspectives and the way forward.

We anticipate the participation of patients, clinicians, pharmacists, nurses, social scientists, community workers, funders, policymakers, graduate students etc. Once the workshop is approved, we will post the full program on the GHD online forum.

In meantime, here is the conference's official website:https://www.confmanager.com/main.cfm?cid=2027

Best regards,

Jean

8:59 PM, 12 Feb 2010 | Permalink

9

Marijn de Bruin

Dear Jean,

thank you. Yes, I was afraid I missed the deadline for abstract submission, but Dr. Jane Simoni forwarded me that the deadline were extended to February 28. So I plan to submit an abstract myself as well (randomized controlled trials to support HIV adherence- or perhaps practical implications following from the meta's). Please note that our meta's specifically did not focus on DOT, but on programs that target fully "autonomous" patient behavior.

Best wishes,
Marijn

4:47 AM, 13 Feb 2010 | Permalink

10

Ann Deschamps

Dear Marijn,

welcome to GDH!
I'm pleased to hear that you will send in an abstract for the IAPAC/NIMH conference. I'm looking forward to meet you there.
Ann Deschamps
Researcher in nursing
Anchor lector internationalisation
University College of Leuven
Department Health and Technology

Ann

5:38 AM, 14 Feb 2010 | Permalink

11

Jean Nachega, MD, PhD

Dear all:

I am pleased to confirm that our workshop proposal:
"Promises and Pitfalls of Directly Observed/Administered Antiretroviral Therapy in Treatment Naive and Experienced-HIV Infected Adults in Developed and Developing Countries" has been approved by the program committee to be presented at the 5th International Conference on HIV Treatment Adherence.

Please find the detailed program below.

We look forward to see you there and let us know if you have any question(s) or comment(s).

Best Wishes,

Jean

-----------------------------------------------------
DOT/DAART-ART Workshop- 5th International HIV Treatment Adherence Conference, May 23, 2010, 12:00 noon-2pm, Eden Roc Renaissance Hotel, Miami Beach, in Miami Beach Florida. Room TBA

•Title of Workshop: Promises and Pitfalls of Directly Observed/Administered Antiretroviral Therapy in Treatment Naïve and Experienced-HIV Infected Adults in Developed and Developing Countries

•Chairs Information: Jean B. Nachega, MD, PhD, Johns Hopkins University, Baltimore, MD, USA & Stellenbosch University, Cape Town, South Africa; ; David R. Bangsberg, MD, MPH, Harvard University, Boston, MA, USA ...

expand comment

7:58 PM, 1 Apr 2010 | Permalink

12

Mateus Kambale Sahani

Thank you for all your comment. I have time to give you more details for challenges in ARV treatment and TB detection and treatment in DRC.
By now you have to know that many people infected by HIV in DRC don't have access to treatment, also the cure rate for TB in Goma city increased in 2009 from 85%-52% but no MDR-TB was been diagnised. I think that in these cases which didn't positively respond to the treatment, there are some MDR-TB cases but we have to confirm this.

Thank you,
Dr Mateus K. Sahani.

12:26 PM, 20 Apr 2010 | Permalink

13

Stephanie Topp

Thanks all for the discussion. The centre for Infectious DIsease Research in Zambia is also starting to examine current practice / thoughts about adherence. One area that interests us is thinking about the relative role of clinicians/counselors in the clinics, in a)stressing adherence b) identifying behaviours / behavioural risk factors in poor adherence and being able to flag them. In the context of a discussion of self-management this becomes even more appropriate since the guidance and opinions of key medical staff (clinicians or lay health staff )may well be considered even more critical.
Unfortunately I can't attend IAPAC but look forward to discussing mroe on this forum.
Steph Topp, ART Integration Coord, CIDRZ, Zambia.

11:11 AM, 21 Apr 2010 | Permalink