HUMANA PEOPLE TO PEOPLE

HUMANA PEOPLE TO PEOPLE is an international movement with 26 national member organisations around the world. The member organisations of HUMANA PEOPLE TO PEOPLE run over 150 projects in 30 countries world wide with the purpose of influencing the development towards minimizing the gab between rich and poor in the world.

45 projects are in the developed part of the world - Europe and USA. And are mainly dealing with generating funds for development projects in the underprivileged part of the world, mostly in Africa. The collection, sorting and selling of second hand clothes plays a central role in generating funds. Partnership in Development agreements with many entities also play an increasing role.

110 projects in 11 countries are in the less developed part of the world - Africa, Asia and Latin America, the majority being in Africa. The projects fall within 10 different main sectors: schools, child aid, fighting HIV/AIDS, commercial companies, fund-raising, refugee and relief aid, tree planting and environment, from communal to commercial farmer, the scholarship program and a program for international volunteers.

The projects are run dedicated Project Leaders of many nationalities. All projects are based on a people to people concept and on mobilizing, organizing and building capacity in each individual and thereby giving people themselves the tools to change their own situation.

TCE - Total Control of the Epidemic

The AIDS epidemic constitutes an urgent and massive threat to development. Since the start of the epidemic two decades ago, HIV has infected more than 53.1 million people. 18.8 million of them have died. Today an estimated 34.3 million people live with HIV/AIDS – 25 million of them live in Sub-Saharan Africa. In the most hard-hit countries the infection rate approaches 40% of the adult population. ?More than 5 million people were infected during 2000. This means that more than 15,000 are infected per day. Approximately 15 million children have been orphaned due to the epidemic, and of these more than 12 million live in Sub- Saharan Africa.

In Zimbabwe, current estimates say that 25-30% of the adult population is living with HIV or AIDS. In Harare alone, 1500 people die every week for the disease.

Whether measured against the yardstick of the increasing 'orphanhood' or the bottom line losses to business, AIDS has never posed a bigger threat to development. As mankind we face a tragedy of great proportions, and a massive and organized effort is needed in order to get the epidemic under control.

HUMANA PEOPLE TO PEOPLE started the TCE program in April 2000. 
The idea of TCE is to mobilize all people in a community to gain Total Control of the Epidemic – area by area, person by person. 
An area is defined by the size of its population: 100,000 people.
A group of 50 people from this area will be contracted as TCE Field Officers in order to step by step, neighbourhood by neighbourhood, person by person, organize, promote, push, and first and foremost talk to each person, again and again, during a period of three years.
The activities within the TCE area equip individuals and communities with the knowledge, the courage, and the skills to take control of their own situation in the face of the epidemic, and enable people to deal with the consequences of AIDS. 
The program addresses every single individual. It mobilizes and trains people to start small-scale income generating productions to earn money to care for the sick and the orphaned. It trains the youth to remain HIV free, teaches better life skills in form of improved nutrition and prevention of opportunistic infections, and it provides an overall attention to and mobilization of people's own resources.

As part of the work in the field the TCE field officers promote Voluntary Counseling and Testing (VCT), Mother to Child Transmission programs, treatments for STD's, and treatment and care of opportunistic infections.

The TCE program complements and promotes the existing programs and institutions in every area.

In Zimbabwe three TCE areas have been started: in April 2000 in Bindura, in November 2000 in Shamva and in March 2001 in Kwekwe. In total 150 TCE Field Officers are every day working in their Fields informing people, starting up activities and helping them getting IN control of the HIV Virus. 

The TCE program creates a movement among people, a movement of understanding, and readiness for change and action, which enables people to take control. 

An Area is considered liberated when more than 80% of its population is living under TCE conditions. These are the TCE conditions, which make up the line of defense to be achieved during the 3-year program:

1. People are well organized to defend the community against the epidemic:

• There is a TCE Committee in every neighborhood. 
• Activists do more to stop the spread of AIDS in their Communities. 

2. All people have thorough knowledge about the epidemic: 

• 95% of all people know how the epidemic is transmitted. 
• 95% of all people know the basic facts about the HIV disease and what it does to the body. 
• 95% of all people know the basic facts of how to support the immune system and how to suppress the HIV virus in the body. 
• A solid majority of the people know their HIV status. 

3. The children and young people are organized to maintain a front against the epidemic:

• All schools in the area have HOPE clubs.
• All schools in the area have AIDS education.
• 50% of youth between 10 and 24 years are organized in Clubs where they do more under the theme "We are free from HIV and we support our Community to deal with the consequences of AIDS".

4. A Safe sex-life is the practice:

• Condoms are easily available, free or at an affordable price all over the area.

5. Vulnerable persons are specifically assisted:

• Men supporting their family as truck drivers, migrant workers or working in the police or the military are sought out and counseled as to how to avoid and cope with HIV/AIDS.
• Sex workers are organized, trained and helped with alternative options of income generation.
• All children between 10 and 19 have received personal counseling by a trained female counselor about how to avoid HIV infection.

6. The health institutions are optimally equipped and organized:

• All clinics in the area have a professional attitude and skills to treat STD's.
• All clinics in the area have stocks of medication to treat STD's.
• All clinics in the area have personnel, equipped with knowledge, attitude and readiness to assist people living with HIV.
• All clinics in the area have medicine in stock that can treat opportunistic infections.(diseases)
• All clinics have the knowledge and skill to counsel HIV infected mothers on how to reduce the risk of infecting the child.
• There are adequate testing facilities.

7. The community is organized to deal with the consequences of the epidemic:

• People living with HIV receive knowledge and skills to live longer and healthier lives.
• All sick people receive care.
• All orphans receive care and support.
• All orphans complete primary school.

8. The community is organized to increase its own income:

• Through increased production.
• Through training and improved techniques.
• Through investment.

Acetyl salicylic acid (Aspirin), Selenium, and Chloroquine in the treatment of HIV infection: 
a three-arm, randomized, placebo-controlled clinical trial.

Carried out for HUMANA PEOPLE TO PEOPLE by

E. N. Sibanda
Dept. of Immunology, Medical School, University of Zimbabwe, Zimbabwe

G.Stanczuk 
Dept. of Obstetrics and Gynaecology, Medical School, University of Zimbabwe, Zimbabwe

M. Thomsen and A. M. Soerensen 
Humana People to People, Total Control of the Epidemic (TCE) program, Murgwi Estates Shamwa, Zimbabwe

Background

The increasing prevalence of Human Immunodeficiency Virus (HIV) infection in Sub-Saharan Africa has had a deleterious effect on the economy and health delivery systems of many countries. Unless effective treatment will be available to everyone in the near future, the pool of the virus will remain high and increasing. This will further disadvantage any preventive methods by increasing infectivity and susceptibility to HIV infection.
The majority of those affected have no income. Even if current efforts to seek drastic reductions in the costs of antiretroviral medicines are crowned with success, this will have little impact on those bearing the brunt of the epidemic. Clinicians working in these environments are forced to watch their patients, friends, relatives and colleagues die for lack of access to drugs that could improve, extend or save their lives. 
It is in this background that we became interested in reports suggesting that chloroquine and aspirin that are readily available and affordable in most African villages may have some effect on HIV. 

We are now reporting on this randomized, placebo-controlled clinical trial to study the effects of ingestion of a combination of either Multivitamins, Aspirin, Chloroquine and Selenium (MACS) or Selenium, Aspirin and Multivitamins (SAM) on the course of HIV infection in asymptomatic individuals with CD4 count above 150.

The program in chronological time order

11/10 to 4/12 2000 : The recruiting period.
TCE field officers from TCE Bindura and Shamva TCE areas recruited HIV positive
persons from their fields. Information meetings were held in Shona and in English.
60 persons signed an informed consent form. 52 came for the recruiting
Bloodtests. 
31 persons qualified for participating in the Pilot Study, as they had CD4 cell counts higher than 150 and were without any symptoms. 
21 persons had already AIDS pr definition and were offered treatment with the therapy that we hoped would be the best. 
Another 3 particpants joined the project at a later stage.
10 of the field officers dedicated themselves specifically to take care of each some
of the participants all the way through the project.

Report on the results of the 31 participants in the Pilot Study.

5th and 6th of December 2000: 
The 31 Study participants started their tablet program divided into 3 groups:

one group receiving placebo ( vitamins without Selenium)
one group receiving SAM ( Selenium, Aspirin, Multivitamin)
one group receiving MACS (Multivitamin, Aspirin, Chloroquine,Selenium).

All groups received same number of tablets. Nobody knew what they received. The clinical doctors did not know what the participants received. 
All tablets - medicines as well as placebos - were donated by 2 Zimbabwean Pharmaceutical Companies, Caps Holding and Varichem.
All participants were supported with nutritious food for the Study period plus 3 months. The food was donated by The Latter Days Saints Church in Harare

11th and 12th of December 2000: 
A checkup on compliance and side-effects was done.
In the following period the field officers visited their participants from the study
group as well as the treatment group once a week to make sure that everybody
coped well with their tablets and that all problems were reported to the responsible
medical team and solved.

19th of January 2001: 
A checkup on health and side-effects was done.

26th and 27th February 2001:
Halfway checkup with blood tests was done. Every month Field Officers visited the participants and distributed food donated to the project from The Latter-day Saints Church in Harare.
4.th and 5th June 2001:
The final checkup by the clinical doctors were done. The final bloodtests for CD4 and viral load were taken. The participants saw their data until now and were told everything about the Pilot Study. All participants were given one year supply of SAM therapy, as we did not know yet which of the therapies would be the best. As SAM is identical with MACS except for the chloroquine it would be easy to add chloroquine in case it would show up to be a much better therapy than SAM.

11th and 12th June 2001:
The participants received their final results which implicated that the SAM therapy proved to be the best. At this time all the participants were taking SAM so it was simple to just decide that they could continue doing that.

Results of the Study Group 

52 (90%) of the 60 consenting persons presented themselves to the investigators for the determination of CD4 T-cells at the start of the study . 
31 HIV positive men and women had CD4 count above 150 and were randomly allocated into three groups. Two were lost for follow-up, 4 had incomplete laboratory data, and one woman became pregnant within first two months of the trial. Twenty-four participants completed the trial.

The demographic data and baseline characteristics of persons randomized to each of the three arms are presented. (table 1).

Table 1. The demographic data and baseline characteristics of the study participants. No statistically significant differences were observed when comparing each variables between each groups at the time of enrolment to the trial.

* calculated from individuals, who had p24 detectable by method used (n=3 in placebo, n=4 in SAM, and n=6 in MACS)

Abrieviated explanations of the tests in table 1:
CD4 cells - essential cells in the immunesystem that are attacked by HIV
CD8 cells - essential cells in the immunesystem that can kill cells infected with viruses.
p24 - a small protein and a part of the HIV virus. It is leaking from the lymphnodes early in
active phases of HIV infection.
ESR - general bloodtest for infections.
Hemoglobin: important protein in the red blood cells.
Platelets : small blood plates that can clot the blood when nescesary.

Clinical and laboratory results on day 0 compared to day 180 in the Study

The clinical and laboratory results of the 24 participants who were evaluated statistically presented in table 2.

Table 2
Comparison of weight, immunological, virological and haematological indices at baseline with values obtained after 6 months of intervention in the three study groups. 
* significant change (p <0.5) [see text.]
** p=0.062
Values less than 0.05 (p= 0.05) is considered statistically significant.

The results described for each group

Placebo group
Seven men completed the study in this group.
The mean age was 32 and the mean body weight was 62 kg.
The body weight in this group increased significantly to mean 64 kg .
The median ESR at the start was 8 and at the end was 14. 
The median CD4+ T lymphocyte count in this group decreased from 510 (range 177-934) level at the beginning to 338 (range115-1140) at the end of the study.
The median values of CD8+ T lymphocyte count increased from 1015 (range 875-2456) to 1230 (range 882-3534)


The viral load increased from mean log. values of 3.26 to 3.69 , a difference of 0.43 log.
This increased viral replication was paralleled by an increase in p24 antigen levels in this group. At the enrollment 5/7 (71%) of the participants were p24 antigen negative. After 6 months that number had decreased to 2/7 (29%) - three of them had detectable p24 antigen in the plasma.

The MACS group
Three men and seven women completed the trial in the MACS group.
Their mean age was 32 and mean weight was 58 kg .
The weight remained constant in this group.
They had relatively high ESR values, median of 58 at the beginning, which decreased significantly after 6 months of therapy, to median 39.
Their median level of CD4 count remained constant at 394 cells.
The CD8 cells count increased slightly from 851 at baseline to 955 at 6 months.
There was a decrease of 0.3 log. in the mean log viral load from 4.3 to 4.0 
In this group, all the participants who were p24 antigen positive at baseline exhibited an increase in p 24 antigen levels after 6 months of trial.
One of three participants who were viral p24 antigen negative at baseline became p24 positive during the 6 months of treatment. 
Two out of ten (20%) of individuals taking MACS combination developed sharply demarcated depigmented areas on the face and arms. 

The SAM group
Three women and four men completed the trial in this group.
Their mean age was 29 and mean weight was 62 kg.
The body weight in this group increased significantly to mean 66 kg.
ESR levels were constant and normal in this group, median from 7 to 8.
There was statistically significant increase in CD4 count from median of 363 at the beginning to 473 at 6 months.
There was also a statistically significant increase in the CD8 count from a baseline mean value of 760 to 1134 . 
The viral load decreased by 0.1 log (from mean log of 4.8 to 4.7).
All three individuals who were p24 antigen negative at enrolment remained negative after the 6 months of the trial. 

Discussion and Conclusion of the data from the Pilot Study

This Study was a Pilot meaning that a few people voluteered to do the job of finding some trenches that can be used by many.
The message of the Pilot Study is clear.
There is evidence that some cheap vitamins, minerals in combination with some cheap drugs (Aspirin and Chloroquine) that are already available even in small African villages can benefit a lot to the health of people with HIV infection and that they even have anti-viral potential.
This anti-viral potential needs urgently to be explored in larger clinical trials and this Pilot Study has given us some guidelines as to be able to know more about the doses, combinations and intervals that should be used.
Such a Study has not been done before, and the doses that we used were pure estimates and common sense from our clinical experiences. The next step is to find out how exactly can these therapies be combined in the right doses and at the right intervals and eventually be used in combination with antiretrovirals in short courses.
The SAM therapy not only increased the CD4 count in that group. When we compare it to the Placebo group it prevented the decrease of CD4 count in this group. 
This effect is comparable to the effect of antiretroviral drugs.
The SAM therapy showed a decrease in Viral load of 0.1 log. 
The placebo group showed an increase of Viral Load of 0.43 log.
Justifiably the two effect could be added because the SAM therapy prevented the in-crease in Viral load at the same time as it had a decrease in itself. 
The total effect on the Viral load would therefore be 0.53, which is a significant effect.
The MACS therapy did not increase the CD4 count. Seemingly the chloroquine neutralised the increase that SAM made. On the other hand MACS group showed a decrease in Viral load of 0.3. If this is added to the prevention of increase in VL from the Placebo group then the total effects on the Viral load was here 0.73 log, which is very significant.
There is still a lot of research to be done on these combinations.

Other results of the program 

In addition to the 31 Study participants , 21 participated in this program as an 
attached group - Group 4.
The people in Group 4 did not qualify for the Study as their HIV infection was too advanced - all of them had very low CD4 counts and the main part of the group had several symptoms and opportunistic diseases. As those people had volunteered and hoped to be included in the Study and as their chances of getting any treatment and care at all were absolutely minimal or absent, it would not have been ethically correct to dismiss them after the first meeting. We therefore offered them treatment with what we thought would show up to be the best treatment. 
They attended all the meetings and clinical sessions as all the 31 participants also did. 
They had the same care, treatment and also food supply - only we did not follow them with Viral load and CD4 counts, as these tests are very expensive and actually make up the main part of the budget.
Despite that the main part of this group were in the advanced and even in the terminal phase of AIDS only 4 of these partcipants died during the 6 months. 

At 6 months the general impression of this group was clinical improvement and well being.
Another 3 persons joined this group during the 6 months period- it was spouses of some of the participants who had been convinced that knowing their HIV status and acting upon it was better.
All 51 participants received SAM therapy for 1 year at the end of the 6 months.
They were informed about all their results and about the content of all the tablets.

Short explanations:
ESR - general blood test for infections.
CD4 cells - essential cells in the immune system that are attacked by HIV
CD8 cells - essential cells in the immune system that can kill cells infected with viruses.
P24 - a small protein and a part of the HIV virus. It is leaking from the lymphnodes early in active phases of HIV infection.
WBC - white blood cells - the total number of immune cells pr milliliter of blood.
Lymphocytes - a section of the wbc - those cells that are dealing mostly with fighting virus.

Acknowlegdements

The Provincial Medical Directorate (Mashonaland Central)

Field Officers (Ruth, Johan, Kingston, Locadia, Martin, Spelile, Theresa, Caspar, Shylett and Francis) 

Johan Boerlaet for useful discussion.

H.S.Armistead, International Project for affordable Therapy for HIV, Los Angeles, California, USA for expierence and discussions

The participants.

Funding

HUMANA PEOPLE TO PEOPLE and The Danish Foundation "Fonden til støtte for humanitære formal, til fremme af forskning og til beskyttelse af naturmiljøet".

Later Day Saints who provided funding for food rations.

Varichem Pharmaceuticals Zimbabwe who donated Placebo and other medications.

CAPS Holdings who donated some medications